Phase II, single-arm trial of preoperative short-course radiotherapy followed by chemotherapy and camrelizumab in locally advanced rectal cancer. Issue 11 (1st November 2021)

• Record Type: Journal Article
• Authors: Lin, Zhenyu; Cai, Ming; Zhang, Peng; Li, Gang; Liu, Tao; Li, Xin; Cai, Kailin; Nie, Xiu; Wang, Jing; Liu, Junli; Liu, Hongli; Zhang, Weikang; Gao, Jingbo; Wu, Chuanqing; Wang, Linfang; Fan, Jun; Zhang, Lan; Wang, Zheng; Hou, Zhiguo; Ma, Chi; Yang, Kunyu; Wu, Gang; Tao, Kaixiong; Zhang, Tao
• Is Part Of: Journal for immunotherapy of cancer. Volume 9:Issue 11(2021)
• Publication Date: 2021-11-01
• Subjects: radiotherapy -- immunotherapy -- gastrointestinal neoplasms -- clinical trials -- phase II as topic; Cancer -- Immunotherapy -- Periodicals; Cancer -- Immunological aspects -- Periodicals; Tumors -- Immunological aspects -- Periodicals; Immunotherapy -- Periodicals; 616.99406105
• DOI: 10.1136/jitc-2021-003554
• Languages: English
• ISSNs: 2051-1426

Abstract

Abstract : Background: In locally advanced rectal cancer (LARC), preoperative short-course radiotherapy (SCRT) with delayed surgery has been shown to be as effective as long-course chemoradiotherapy, with only modest benefits. This study aimed to evaluate the efficacy and safety of preoperative SCRT combined with subsequent CAPOX (capecitabine and oxaliplatin) and the anti-PD-1 antibody camrelizumab in patients with LARC. Methods: This was a prospective, single-arm, phase II trial. Treatment-naïve patients with histologically confirmed T3-4N0M0 or T1-4N+M0 rectal adenocarcinoma received 5×5 Gy SCRT with two subsequent 21-day cycles of CAPOX plus camrelizumab after 1 week, followed by radical surgery after 1 week. The primary endpoint was pathological complete response (pCR) rate. Biomarker analysis was performed to identify a potential predictor of pCR to treatment. Results: From November 7, 2019 to September 14, 2020, 30 patients were enrolled, and 27 patients received at least one dose of CAPOX plus camrelizumab. Surgery was performed in 27 (100%) patients. The pCR (ypT0N0) rate was 48.1% (13/27), including 46.2% (12/26) for proficient mismatch repair (MMR) tumors and 100% (1/1) for deficient MMR tumors. Immune-related adverse events were all grade 1–2, with the most common being reactive cutaneous capillary endothelial proliferation (81.5%). No grade 4/5 adverse events occurred. Biomarker analysis showed patients without FGFR1–3 deletions had a better tendency for pCR. Conclusions: SCRT combined with subsequent CAPOX plus camrelizumab followed by delayed surgery showed a favorable pCR rate with good tolerance in patients with LARC, especially in the proficient MMR setting. A randomized controlled trial is ongoing to confirm these results. Trial registration number: ClinicalTrials.gov identifier: NCT04231552 .