Actively Recruiting
Chemoradiotherapy and Anti-PD-1 Antibody in Anal Squamous Cell Cancer：Chase
Led by Fudan University · Updated on 2026-04-29
241
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Squamous cell carcinoma (SCC) of the anus is a rare malignancy. For localized anal squamous cell carcinoma , definitive chemoradiotherapy is the standard treatment. Patients who do not achieve complete response （CR）or experience recurrence require radical surgery with permanent colostomy. In previous studies of anal squamous cell carcinoma （ASCC）, although favorable response rates were achieved after concurrent chemoradiotherapy, high rates of local recurrence and distant metastasis were also observed in patients with locally advanced disease, which adversely affect patient survival. Clinical studies have demonstrated that single-agent PD-1/PD-L1 inhibitors, including nivolumab and pembrolizumab, show promising efficacy in advanced anal squamous cell carcinoma. Given the high recurrence rate associated with current concurrent chemoradiotherapy regimens and the characteristics of the immune microenvironment in anal cancer, the combination of immunotherapy with concurrent chemoradiotherapy is expected to improve therapeutic outcomes. Therefore, we designed this prospective, multicenter, phase II clinical study to investigate the efficacy and safety of concurrent chemoradiotherapy combined with immune checkpoint inhibitors in anal cancer. This study aims to enhance the therapeutic effect for patients with locally advanced, recurrent, or metastatic anal squamous cell carcinoma and reduce adverse events in patients with high-risk factors after local excision or in early-stage disease. The primary endpoints are local tumor control rate, overall survival, and radiation-related toxicity. The results will provide evidence for subsequent randomized controlled trials.
CONDITIONS
Official Title
Chemoradiotherapy and Anti-PD-1 Antibody in Anal Squamous Cell Cancer：Chase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Diagnosed with squamous cell carcinoma of the anal canal or perianal region
- ECOG performance status 0 or 1 with life expectancy of at least 3 months
- Adequate organ function including specific blood counts, liver, kidney, and thyroid function within defined limits
- No severe comorbidities expected to limit survival to less than 5 years
- Negative pregnancy test for women of childbearing potential or permanently non-childbearing
- Agreement to use effective contraception during the study and for 12 months after treatment
- Ability and willingness to comply with study visits, treatment, and tests
- Cohort-specific criteria including tumor size and lymph node status, prior treatments, and metastasis presence as detailed in the study
You will not qualify if you...
- Diagnosis of other anal tumors such as gastrointestinal stromal tumor, lymphoma, or melanoma
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
- Previous or current other malignancies except certain treated skin, cervical, or thyroid cancers
- Active or history of autoimmune diseases except some stable thyroid conditions, type 1 diabetes, vitiligo, or resolved childhood asthma/allergy
- Immunodeficiency conditions including positive HIV test or history of organ or bone marrow transplant
- History of interstitial lung disease or non-infectious pneumonitis
- Active or recent pulmonary tuberculosis
- Active hepatitis B or hepatitis C infection
- Severe heart, lung, liver, or kidney dysfunction
- History of substance abuse, alcoholism, or drug addiction
- Other medical, psychiatric, or social conditions that may affect safety or study compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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