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Jiandong Zhang,1,* Kai Zhao,1,* Weihang Zhou,1 Guixing Jiang,1 Ying Ding,2 Yizhuo Zhang,1 Xinyu Dong,1 Defei Hong,1 Xiaolong Liu1 1Department of General Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, People’s Republic of China; 2Department of Intensive Care Unit, Sir Run Run Shaw Hospital Qiantang Campus, Zhejiang University School of Medicine, Hangzhou, People’s Republic of China*These authors contributed equally to this workCorrespondence: Xiaolong Liu, Department of General Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, No. 3 Qingchun East Road, Shangcheng District, Hangzhou, 310020, People’s Republic of China, Tel +86-13588457667, Email liuxiaolong@zju.edu.cn Defei Hong, Department of General Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, No. 3 Qingchun East Road, Shangcheng District, Hangzhou, 310020, People’s Republic of China, Email hongdefi@163.comBackground: Pancreatic ductal adenocarcinoma (PDAC) is one of the most malignant tumors, with approximately 80% of PDAC patients having locally advanced or metastatic disease at diagnosis. The liver is a predominant site of metastasis and is linked to a particularly poor prognosis. Here, we explored camrelizumab (an anti-programmed cell death-1 antibody) combined with albumin-bound paclitaxel and gemcitabine (AG) in patients with PDAC and liver metastases (PCLM).Methods: In this pilot trial (ChiCTR2000038587), patients received camrelizumab (200 mg on day 1) plus gemcitabine (1000 mg/m2 on days 1 and 8) and albumin-bound paclitaxel (125 mg/m2 on days 1 and 8) every 21-day cycle until disease progression, intolerable toxicity, or death. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety. Exploratory analyses evaluated potential biomarkers associated with survival.Results: From October 2018 to October 2023, 17 patients were enrolled. The median OS was 14.0 months (95% confidence interval [CI], 10.0– 24.0) and the median PFS was 6.4 months (95% CI, 5.2– 10.2). Five patients achieved an objective response (29.4%), with a DCR of 64.7%. Fewer liver metastasis lesions, higher white blood cell-to-lymphocyte ratio, and lower neutrophil-to-lymphocyte ratio were associated with improved PFS and OS (P< 0.05). Grade 3 treatment-related adverse events (TRAEs) included platelet count decreased (2 [11.8%]) and neutrophil count decreased (1 [5.9%]). No grade 4 or 5 TRAEs occurred.Conclusion: Camrelizumab combined with AG demonstrates promising antitumor activity in patients with PCLM, with an acceptable safety profile.Keywords: camrelizumab, chemotherapy, pancreatic ductal adenocarcinoma, liver metastases

Due to elevated blood pressure, the treatment reverted to pembrolizumab monotherapy in early May 2022, with concurrent bone protective therapy. Following his discharge in July 2022, the patient has continued maintenance immunotherapy with pembrolizumab to date, still alive and with a good quality of life.” The corrected sentence appears below: “In late September 2021, the patient began treatment with camrelizumab combined with bevacizumab for eight cycles until early April 2022, during which period a chest and full abdomen enhanced CT evaluation showed stable disease. Due to elevated blood pressure, the treatment reverted to camrelizumab monotherapy in early May 2022, with concurrent bone protective therapy. Following his discharge in July 2022, the patient has continued maintenance immunotherapy with camrelizumab to date, still alive and with a good quality of life.”

Lingran Zhou, Zhenchao Tao, Yan Zhou, Liping Yang, Yangyang Zhang, Jian He, Bin Sun, Ru Wang, Jing Yang, Jin Gao Department of Radiation Oncology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People’s Republic of ChinaCorrespondence: Jin Gao, Department of Radiation Oncology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People’s Republic of China, Email gjfl2011@126.comBackground and Purpose: Nasopharyngeal carcinoma (NPC) is a malignancy with distinct geographical distribution and is rare in non-endemic regions. Despite significant improvements in NPC survival through chemoradiotherapy, recurrence and metastasis remain major clinical challenges, particularly in non-endemic areas where data on neoadjuvant immunochemotherapy are scarce. This study aimed to address this gap by evaluating the antitumor activity and safety of neoadjuvant gemcitabine–cisplatin plus camrelizumab in patients with locally advanced NPC in non-endemic regions.Materials and Methods: In this single-center, single-arm, phase 2 trial, patients with stage III–IVA NPC received chemotherapy (gemcitabine 1000 mg/m2 on days 1 and 8, plus cisplatin 80 mg/m2 on day 1) and camrelizumab 200 mg on day 1 for three cycles, followed by radiotherapy. Primary endpoints were objective response rate (ORR). Secondary endpoints included disease-free survival (DFS), overall survival (OS), and biomarker correlations in addition to the primary ORR.Results: Thirty-eight patients were enrolled and thirty-three completed three cycles of the neoadjuvant therapy, resulting in an ORR of 89.4% (34/38). The median follow-up duration was 18.5 months, and the 12-month disease-free survival rate was 94.7% (34/36). Six patients encountered grade 3 adverse effects: Two with nausea/vomiting, two with thrombocytopenia, one with leukopenia, and one with immune-related hepatitis. No grade 4 treatment-related events or deaths occurred.Conclusion: Neoadjuvant camrelizumab combined with chemotherapy demonstrated promising antitumor activity and acceptable safety in locally advanced NPC patients from non-endemic regions. However, further randomized studies are needed to confirm these findings and assess long-term survival benefits.Keywords: neoadjuvant chemoimmunotherapy, PD-1 inhibitor, camrelizumab, nasopharyngeal carcinoma, radiotherapy

This study aimed to assess the prognostic significance of alpha-fetoprotein (AFP) response in patients with unresectable hepatocellular carcinoma (u-HCC) who underwent hepatic artery infusion chemotherapy (HAIC) combined with lenvatinib and camrelizumab. A retrospective review was conducted on patients with u-HCC receiving treatment with HAIC combined with lenvatinib and camrelizumab. Early AFP response was defined as a >20% decrease in AFP within 4 weeks, and AFP response as a >75% decrease in AFP within 8 weeks. The correlation between early AFP response, AFP response, therapeutic response, overall survival (OS), and progression-free survival (PFS) was investigated. The study included 63 patients. AFP responders exhibited superior objective response rates compared to AFP non-responders, as determined by RECIST v1.1 or mRECIST criteria (45.5 vs. 18.2%, =0.014, or 81.8 vs. 48.5%, =0.013). Furthermore, early AFP responders demonstrated prolonged OS (not reached vs. 8.0 months, <0.001) and PFS (13.3 vs. 3.0 months, = 0.018) relative to early AFP non-responders. Similarly, AFP responders exhibited improved OS (not reached vs. 9.0 months, <0.001) and PFS (19.3 vs. 5.1 months, =0.002) compared to AFP non-responders. Multivariate analysis results indicated that both early AFP response and AFP response independently predicted OS [hazard ratio (HR) 2.963, 95% confidence interval (CI) 1.333-6.585, =0.008, and HR 6.182, 95% CI 1.780-21.466, =0.004] and PFS (HR 2.186, 95% CI 1.107-4.318, =0.024, and HR 3.078, 95% CI 1.407-6.730, =0.005), serving as significant prognostic values. Early AFP response and AFP response serve as predictive biomarkers for the effectiveness of HAIC combined with lenvatinib and camrelizumab in patients with u-HCC.

[This corrects the article DOI: 10.3389/fimmu.2022.956982.].[This corrects the article DOI: 10.3389/fimmu.2022.956982.].

BackgroundThe current second-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma remains unsatisfactory. Anti-PD-1 monoclonal antibody combined with anti-angiogenic therapy shows anti-tumor activity and synergistic effect. We aimed to assess the efficacy and safety of the combination therapy of camrelizumab, apatinib, and S-1 in patients with gastric or gastroesophageal junction adenocarcinoma. MethodsIn this open-label, single-arm, phase 2 trial, in each 21-day cycle, eligible patients received 200 mg intravenous camrelizumab in the first day, 500 mg oral apatinib once daily continuously, and specific dose oral S-1 in the first 14 days until the trial was discontinued disease progression, development of intolerable toxicity, or withdrawal of consent. The primary endpoint was objective response rate. The secondary endpoints were disease control rate, progression-free survival and overall survival, and safety. This study was registered at ClinicalTrials.gov, NCT04345783.ResultsBetween May 2019 and August 2020, we enrolled a total of 24 patients in this trial. At the data cutoff (December 1, 2020), the median follow-up duration was 8.13 months. Seven of 24 (29.2%, 95%CI 14.9–49.2%) patients reached objective response. The median-progression-free survival was 6.5 months (95%CI 6.01–6.99) and the median overall survival was not reached. Grade 3 or 4 adverse events occurred in 6 (25.0%) patients, including elevated transaminase, thrombocytopenia, fatigue, proteinuria, and intestinal obstruction. No serious treatment-related adverse events or treatment-related deaths occurred.ConclusionsIn this trial, the combination of camrelizumab, apatinib, and S-1 showed promising anti-tumor activity and manageable toxicity as a second-line therapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma, regardless of PD-L1 expression.Clinical trial registrationNCT04345783.

Background Effective therapeutic options are limited for patients with advanced esophageal squamous cell carcinoma (ESCC). The incorporation of an immune checkpoint inhibitor and a molecular anti‐angiogenic agent into the commonly adopted chemotherapy may produce synergistic effects. Therefore, we aimed to investigate the efficacy and safety of camrelizumab plus apatinib combined with chemotherapy as the first‐line treatment of advanced ESCC. Methods In this single‐arm prospective phase II trial, patients with unresectable locally advanced or recurrent/metastatic ESCC received camrelizumab 200 mg, liposomal paclitaxel 150 mg/m2, and nedaplatin 50 mg/m2 on day 1, and apatinib 250 mg on days 1‐14. The treatments were repeated every 14 days for up to 9 cycles, followed by maintenance therapy with camrelizumab and apatinib. The primary endpoint was objective response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (version 1.1). Secondary endpoints included disease control rate (DCR), progression‐free survival (PFS), overall survival (OS), and safety. Results We enrolled 30 patients between August 7, 2018 and February 23, 2019. The median follow‐up was 24.98 months (95% confidence interval [CI]: 23.05‐26.16 months). The centrally assessed ORR was 80.0% (95% CI: 61.4%‐92.3%), with a median duration of response of 9.77 months (range: 1.54 to 24.82+ months). The DCR reached 96.7% (95% CI: 82.8%‐99.9%). The median PFS was 6.85 months (95% CI: 4.46‐14.20 months), and the median OS was 19.43 months (95% CI: 9.93 months – not reached). The most common grade 3‐4 treatment‐related adverse events (AEs) were leukopenia (83.3%), neutropenia (60.0%), and increased aspartate aminotransferase level (26.7%). Treatment‐related serious AEs included febrile neutropenia, leukopenia, and anorexia in one patient (3.3%), and single cases of increased blood bilirubin level (3.3%) and toxic epidermal necrolysis (3.3%). No treatment‐related deaths occurred. Conclusions Camrelizumab plus apatinib combined with liposomal paclitaxel and nedaplatin as first‐line treatment demonstrated feasible anti‐tumor activity and manageable safety in patients with advanced ESCC. Randomized trials to evaluate this new combination strategy are warranted. Trial registration This trial was registered on July 27, 2018, at ClinicalTrials.gov (identifier: NCT03603756).

Background Association of immune-related adverse events with tumor response has been reported. Reactive cutaneous capillary endothelial proliferation (RCCEP) is the most common adverse event related to camrelizumab, an immune checkpoint inhibitor, but lack of comprehensive analyses. In this study, we conducted comprehensive analyses on RCCEP in advanced hepatocellular carcinoma (HCC) patients treated with camrelizumab monotherapy. Methods Data were derived from a Chinese nationwide, multicenter phase 2 trial of camrelizumab in pre-treated advanced HCC. The occurrence, clinicopathological characteristics, and prognostic value of RCCEP were analyzed. Results With a median follow-up of 12.5 months, 145 of the 217 camrelizumab-treated patients (66.8%) experienced RCCEP (all grade 1 or 2). RCCEP occurred on the skin surface, mainly on the skin surface of head, face, and trunk. RCCEP could be divided into 5 types including “red-nevus-like,” “pearl-like,” “mulberry-like,” “patch-like,” and “tumor-like,” according to the morphological features. RCCEP biopsy and pathology showed capillary endothelial hyperplasia and capillary hyperplasia in dermis. Significant association between RCCEP occurrence with higher objective response rate was observed (19.3% vs. 5.6%; one-sided p = 0.0044). Compared with those without RCCEP, patients with RCCEP had prolonged progression-free survival (median PFS; 3.2 months vs. 1.9 months; one-sided p < 0.0001) and overall survival (median OS; 17.0 months vs. 5.8 months; one-sided p < 0.0001). In multivariable analyses, the development of RCCEP was significantly associated with prolonged PFS and OS after adjusting for baseline covariates. In addition, the landmark analyses of PFS and OS were consistent with the unadjusted analysis. Conclusions RCCEP occurred on the skin surface and was an immune response of skin capillary endothelial cells. RCCEP occurrence positively associated with outcomes of camrelizumab in advanced HCC.

Aim: This study aimed to report the efficacy and safety of trans -arterial chemoembolization (TACE) plus lenvatinib and camrelizumab in patients with advanced hepatocellular carcinoma (HCC). Methods: This retrospective study enrolled 22 patients with advanced HCC from March 2018 to December 2019. All the patients received comprehensive treatment with TACE plus lenvatinib followed by camrelizumab. Overall survival (OS) and progression-free survival (PFS) were calculated and analysed using the Kaplan-Meier method and log-rank test. Treatment response and adverse events (AEs) were also evaluated. Results: The objective response rate (ORR) and disease control rate (DCR) for the whole cohort were 68.2 and 100% at the first month and 72.7 and 95.5% at the third month, respectively. The median OS was 24 months (95% CI, 20.323–27.677 months), and the median PFS was 11.4 months (95% CI, 8.846–13.954 months). The majority of treatment-related adverse reactions were mild or moderate, except for 4 that developed to grade 3–4 (3 reactions of grade 3, 1 reaction of grade 4). No deaths or other serious adverse reactions occurred. Conclusion: Trans -arterial chemoembolization plus lenvatinib and camrelizumab shows good results incontrolling tumour progression and prolonging median OS in patients with advanced HCC.

Objective: Camrelizumab is the first domestic PD-1inhibitor approved to be combined with chemotherapy as a first-line therapy for advanced nonsquamous non–small-cell lung cancer (NSCLC) in China. The purpose of this study was to determine whether using camrelizumab in the first-line setting is cost-effective in China when compared with traditional chemotherapy or the imported PD-1inhibitor pembrolizumab. Material and Methods: A Markov model was built to simulate 3-week patient transitions over a 30-year horizon from the perspective of the Chinese healthcare system. Health states included stable disease, first progression, second progression, and death. A direct comparison between first-line camrelizumab in combination with pemetrexed and carboplatin (CPC) and pemetrexed plus carboplatin (PC) was performed by calculating transition probabilities from the CameL trial. An indirect comparison between first-line CPC and pembrolizumab in combination with pemetrexed and platinum (PPP) was performed by calculating transition probabilities using a network meta-analysis. Costs in the Chinese setting were collected from the local public database and literatures. Sensitivity analyses explored the uncertainty around model parameters. Results: In the primary analysis, first-line CPC gained an additional 0.41 quality-adjusted life-years (QALYs) with an incremental cost of$3,486 compared with PC, resulting in an incremental cost-effectiveness ratio (ICER) of $ 8,378 per QALY gained. In the secondary analysis, first-line PPP yielded an additional 0.10 QALYs at an incremental cost of$6,710, resulting in an ICER of $ 65,563 per QALY gained. Conclusion: For Chinese patients with advanced nonsquamous NSCLC without targetable genetic aberrations, our primary analysis results supported first-line CPC as a cost-effective treatment compared with traditional PC chemotherapy. The findings of our secondary analysis suggested that first-line PPP would not be a cost-effective option compared with first-line CPC. This analysis provided strong evidence for promoting the widespread use of first-line CPC in China and, to some extent, stimulated the enthusiasm for the development of domestic cancer drugs.