OncoMatch/Clinical Trials/NCT07692152
Sintilimab Versus Mitomycin in Combination With Capecitabine and IMRT for Limited-stage Anal Squamous Cell Carcinoma
Is NCT07692152 recruiting? Yes, currently enrolling (Jul 2026). This Phase 3 trial studies multiple treatments including Sintilimab and Capecitabine for anal squamous cell carcinoma, limited-stage.
Treatment: Capecitabine · Sintilimab · Mitomycin (MMC) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Disease stage
Required: Stage CT2-T4N0M0, CTANYN+M0 (other)
Staged as cT2-T4N0M0 or cTanyN+M0 by imaging (AJCC 9th)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: antitumor immunotherapy (anti-CTLA-4, anti-PD-1, anti-PD-L1)
Exception: anti-HPV vaccination
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
Cannot have received: radiotherapy to the planned radiation site
No prior radiotherapy to the planned radiation site
Cannot have received: tumor resection surgery (other than biopsy)
No prior tumor resection surgery (other than biopsy)
Cannot have received: chemotherapy
No prior ... chemotherapy
Cannot have received: other anti-tumor therapy
No prior ... other anti-tumor therapy
Lab requirements
Blood counts
WBC ≥3 × 10^9/L, ANC ≥1.5 × 10^9/L, Hb >90 g/L, PLT >100 × 10^9/L
Kidney function
serum creatinine <1.5x ULN
Liver function
AST and ALT <2.5x ULN; bilirubin ≤1.5x ULN
Adequate organ function reserve: WBC ≥3 × 10^9/L, ANC ≥1.5 × 10^9/L, Hb >90 g/L, PLT >100 × 10^9/L; AST and ALT <2.5x ULN; bilirubin ≤1.5x ULN; creatinine <1.5x ULN; INR/PT/APTT ≤1.5x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07692152 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage CT2-T4N0M0 or CTANYN+M0 is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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