Sintilimab Versus Mitomycin in Combination With Capecitabine and IMRT for Limited-stage Anal Squa… (NCT07692152) | Clinical Trial Compass
RecruitingPhase 3
Sintilimab Versus Mitomycin in Combination With Capecitabine and IMRT for Limited-stage Anal Squamous Cell Carcinoma
China350 participantsStarted 2026-03-17
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histopathologically confirmed primary anal squamous cell carcinoma, including a subset of rectal squamous cell carcinomas. Definition for inclusion of rectal squamous cell carcinomas: According to Williams' criteria (1979) and WHO classification (2019), rectal squamous cell carcinomas included in this study must meet all of the following criteria: (1) Histopathologically confirmed as pure squamous cell carcinoma, excluding adenosquamous carcinoma; (2) Digital examination/endoscopy/MRI confirmation that the tumor mass is entirely located in the rectum (above the dentate line), with no evidence of primary origin in the anal canal or upward spread. If the inferior border of the tumor is within 5-6 cm from the anal verge, and the patient is scheduled to undergo radical radiotherapy and chemotherapy, the rectal squamous cell carcinoma can be diagnosed and screened for inclusion (When the primary epicenter cannot be determined, regardless of which side the tumor mass is biased towards, the diagnosis shall be considered for screening and inclusion as anal squamous cell carcinoma); (3) Female patients must be excluded for rectal metastasis from cervical squamous cell carcinoma (baseline gynecological examination is recommended).
. Staged as cT2-T4N0M0 or cTanyN+M0 by imaging (AJCC 9th).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Complete Response (cCR) Rate
Timeframe: 6 months after radiotherapy
2
Grade ≥3 acute TRAEs
Timeframe: From the start of local treatment to 90 days after the completion of treatment
Trial details
NCT IDNCT07692152
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. No prior tumor resection surgery (other than biopsy) or chemotherapy or other anti-tumor therapy.
. Aged 18-75 years old.
. ECOG performance status of 0-1.
. Adequate organ function reserve: white blood cell (WBC) count ≥3 × 10\^9/L, absolute neutrophil count (ANC) ≥1.5 × 10\^9/L, hemoglobin (Hb) level \>90 g/L, platelet (PLT) count \>100 × 10\^9/L; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels \<2.5 times the upper limit of normal (ULN); serum bilirubin level ≤1.5 × ULN; serum creatinine (Cr) level \<1.5 × ULN; international normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤1.5 × ULN.
. No known history of allergy to the study drugs.
. No prior radiotherapy to the planned radiation site.
Exclusion criteria
. Perianal squamous cell carcinoma originating from the perianal skin without invasion of the anal canal or anal sphincter. (For tumors with an ill-defined primary site, if clinical judgment indicates the main tumor mass involves the anal canal or is associated with anal sphincter invasion requiring sphincter-preserving chemoradiotherapy, the patient is eligible for inclusion.)
. Perianal Paget's disease.
. Pregnant or lactating women.
. Severe comorbidities or any medical/psychiatric condition deemed unsuitable for participation in this study.
. Patients with prior antitumor immunotherapy (e.g., anti-CTLA-4, anti-PD-1, or anti-PD-L1 monoclonal antibodies, etc.), with the exception of anti-HPV vaccination.
. History of other malignancies diagnosed within the past 3 years, except for curatively treated basal cell carcinoma of the skin and/or completely resected carcinoma in situ of the cervix, breast, or thyroid.
. Requires chronic use of immunosuppressive medications.
. Patients with severe autoimmune diseases, including but not limited to: symptomatic interstitial lung disease, or active infectious/non-infectious pneumonia; active inflammatory bowel disease (including Crohn's disease, ulcerative colitis); rheumatoid arthritis; scleroderma; systemic lupus erythematosus; autoimmune vasculitis; myasthenia gravis; myositis; autoimmune hepatitis; antiphospholipid syndrome; Wegener's granulomatosis; Sjögren's syndrome; Guillain-Barré syndrome; or multiple sclerosis, etc.