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Compares treatment options for Anal Squamous Cell Carcinoma, Limited-stage
Official title Sintilimab Versus Mitomycin in Combination With Capecitabine and IMRT for Limited-stage Anal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07692152
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for anal squamous cell carcinoma, limited-stage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histopathologically confirmed primary anal squamous cell carcinoma, including a subset of rectal squamous cell carcinomas. Definition for inclusion...
- Staged as cT2-T4N0M0 or cTanyN+M0 by imaging (AJCC 9th).
- 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.
You likely can't join if
- Perianal squamous cell carcinoma originating from the perianal skin without invasion of the anal canal or anal sphincter. (For tumors with an...
- 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...
- History of other malignancies diagnosed within the past 3 years, except for curatively treated basal cell carcinoma of the skin and/or completely...
See the full eligibility 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...
- Staged as cT2-T4N0M0 or cTanyN+M0 by imaging (AJCC 9th).
- 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...
- No known history of allergy to the study drugs.
- No prior radiotherapy to the planned radiation site.
- Non-pregnant and non-lactating women.
- For HIV-positive patients: at the initiation of the study, a stable combined antiretroviral therapy (CART) regimen must be used, with an HIV viral load of \ 300/µL. Patients will be closely monitored during the study...
- Signed informed consent form.
- 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...
- 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...
- History of organ transplantation or allogeneic stem cell transplantation.
- Patients with laboratory test values not meeting the relevant criteria within 7 days prior to enrollment.
- Patients with significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function.
- Patients with severe, uncontrolled medical conditions or infections. Examples include: severe myocardial infarction, heart failure, unstable angina, or unstable arrhythmia within the past 6 months; respiratory failure...
- Concurrent use of other investigational drugs or participation in other clinical trials.
- Patients who refuse or are unable to sign the informed consent form for participation in the trial.
- Patients with known allergies or contraindications to the investigational anti-tumor drug or any of its excipients.
- Patients deemed by the investigator to be unsuitable for participation in the study and unlikely to comply with the study procedures, restrictions, and requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.