Condition: Anal Squamous Cell Carcinoma, Limited-stage · Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
This is a prospective, multicenter, open-label, phase III randomized controlled clinical trial designed to evaluate the efficacy and safety of replacing the traditional chemotherapeutic drug mitomycin with the PD-1 inhibitor sintilimab in definitive chemoradiotherapy for limited-stage anal squamous cell carcinoma. The study plans to enroll 350 previously untreated patients with limited-stage anal squamous cell carcinoma and randomize them in a 1:1 ratio into two groups: the control group will receive the current standard treatment, namely intensity-modulated radiotherapy (IMRT) concurrent with capecitabine and mitomycin; the experimental group will receive an innovative "immunotherapy replacement" regimen, namely IMRT of the same technique concurrent with capecitabine and sintilimab. The study adopts a dual primary endpoint design, aiming to verify that the experimental group is non-inferior to the control group in the clinical complete response rate at 6 months after radiotherapy, and is significantly superior to the control group in the incidence of grade 3 or higher treatment-related acute toxicities.
This description comes directly from the study's public registry record.
Yangmei Zhou, MD, PhD · +86 0755-66618168-51251 · szchiec@163.com
Yuan Tang, MD, PhD · +86-15011304945 · tangyuan82@126.com
Always discuss trial participation with your own doctor first.
| National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Beijing, Beijing Municipality, China | Recruiting |
| National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen | Shenzhen, Guangdong, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07692152