RecruitingPhase 2

Chemoradiotherapy and Anti-PD-1 Antibody in Anal Squamous Cell Cancer：Chase

China241 participantsStarted 2024-04-01

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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: This study consists of four cohorts. Inclusion and exclusion criteria comprise general inclusion criteria, cohort-specific inclusion criteria, general exclusion criteria, and cohort-specific exclusion criteria. General Inclusion Criteria Age 18-75 years, male or female; Pathologically confirmed squamous cell carcinoma of the anal canal or perianal region; ECOG performance status 0-1 and life expectancy ≥ 3 months; Adequate organ function:(1) Absolute neutrophil count ≥ 1.5 ×10⁹/L; platelet count ≥ 100 ×10⁹/L; hemoglobin ≥ 9 g/dL; serum albumin ≥ 3 g/dL;(2) Thyroid-stimulating hormone (TSH) ≤ 1 × upper limit of normal (ULN), with normal T3 and T4;(3) Bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2 × ULN;(4) Serum creatinine ≤ 1.5 × ULN, creatinine clearance ≥ 60 mL/min;(5) International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN, unless the patient is on anticoagulation with PT within the expected therapeutic range; activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN; No severe comorbidities expected to limit survival to \< 5 years; Female subjects: negative pregnancy test (if of childbearing potential) or permanently non-childbearing potential; Sexually active males and females of childbearing potential must agree to use effective contraception during the entire study period and for 12 months after completion of study treatment; Written and dated informed consent indicating the patient has been informed of all relevant aspects of the study; …

What they're measuring

Complete response rate

Timeframe: 1 month after the surgery or the decision of Watch and wait

Severe acute toxicity.

Timeframe: from the start of radiotherapy to 3 months after the start of radiotherapy

12-month progression-free survival (PFS).

Timeframe: The proportion of patients who were alive and progression-free from the start of initial treatment up to 12 months.

Trial details

NCT IDNCT07555678

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Anal Squamous Cell Cancer trials