{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T08:38:40Z","timestamp":1791362320788,"version":"4.3.1"},"reference-count":46,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2024,6,20]],"date-time":"2024-06-20T00:00:00Z","timestamp":1718841600000},"content-version":"unspecified","delay-in-days":19,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81872484"],"award-info":[{"award-number":["81872484"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82073365"],"award-info":[{"award-number":["82073365"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"name":"the Social Development Fund of Jiangsu Province","award":["BE2019605"],"award-info":[{"award-number":["BE2019605"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2024,3,29]]},"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Previous studies have suggested the potential synergistic antitumor activity when combining immune checkpoint inhibitors with anti-angiogenic agents in various solid tumors. We aimed to assess the efficacy and safety of camrelizumab (a humanized programmed cell death-1 antibody) plus apatinib (a vascular endothelial growth factor receptor tyrosine kinase inhibitor) for patients with advanced mucosal melanoma (MM), and explore-related biomarkers.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted a single-center, open-label, single-arm, phase II study. Patients with unresectable or recurrent\/metastatic MM received camrelizumab and apatinib. The primary endpoint was the confirmed objective response rate (ORR).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Between April 2019 and June 2022, 32 patients were enrolled, with 50.0% previously received systemic therapy. Among 28 patients with evaluable response, the confirmed ORR was 42.9%, the disease control rate was 82.1%, and the median progression-free survival (PFS) was 8.05 months. The confirmed ORR was 42.9% (6\/14) in both treatment-na\u00efve and previously treated patients. Notably, treatment-na\u00efve patients had a median PFS of 11.89 months, and those with prior treatment had a median PFS of 6.47 months. Grade 3 treatment-related adverse events were transaminase elevation, rash, hyperbilirubinemia, proteinuria, hypertension, thrombocytopenia, hand-foot syndrome and diarrhea. No treatment-related deaths were observed. Higher tumor mutation burden (TMB), increased T-cell receptor (TCR) diversity, and altered receptor tyrosine kinase (RTK)\/RAS pathway correlated with better tumor response.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Camrelizumab plus apatinib provided promising antitumor activity with acceptable toxicity in patients with advanced MM. TMB, TCR diversity and RTK\/RAS pathway genes were identified as potential predictive biomarkers and warrant further validation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>Chinese Clinical Trial Registry, ChiCTR1900023277.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/jitc-2023-008611","type":"journal-article","created":{"date-parts":[[2024,6,22]],"date-time":"2024-06-22T00:35:14Z","timestamp":1719016514000},"page":"e008611","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":21,"title":["Single-arm study of camrelizumab plus apatinib for patients with advanced mucosal melanoma"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct03086174","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04091217","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Lianjun","family":"Zhao","sequence":"first","affiliation":[{"name":"The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China"},{"name":"Clinical Cancer Institute of Nanjing University, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Ren","sequence":"additional","affiliation":[{"name":"The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China"},{"name":"Clinical Cancer Institute of Nanjing University, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guiying","family":"Zhang","sequence":"additional","affiliation":[{"name":"The Comprehensive Cancer Center of Nanjing Drum Tower Hospital Clinical College of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelin","family":"Zheng","sequence":"additional","affiliation":[{"name":"The Comprehensive Cancer Center of Nanjing Drum Tower Hospital Clinical College of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiayu","family":"Wang","sequence":"additional","affiliation":[{"name":"The Comprehensive Cancer Center of Nanjing Drum Tower Hospital Clinical College of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, 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Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruihe","family":"Lai","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lin","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Pathology of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rui","family":"Mei","sequence":"additional","affiliation":[{"name":"Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yitao","family":"Wang","sequence":"additional","affiliation":[{"name":"Jiangsu Hengrui Pharmaceuticals Co., Ltd, 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