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

NCT07555678 | Recruiting Phase 2

• 1 other identifier: Chase1
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anal Squamous Cell Cancer

Keywords

Anal Squamous Cell Cancer; immunotherapy; chemoradiotherapy

Outcome Measures

Primary Outcomes (3)

• Complete response rate

  the primary endpoint of cohort 3 is CR rate including cCR and pCR

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

• Severe acute toxicity.

  The primary endpoint for Cohort 1 (early anal squamous cell carcinoma) and Cohort 2 (post-local excision anal squamous cell carcinoma) is the rate of severe adverse events.

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

• 12-month progression-free survival (PFS).

  The primary endpoint for Cohort 4 (recurrent or metastetic anal squamous cell carcinoma) is 12-month progression-free survival (PFS).

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

Study Arms (4)

Early stage anal squamous cell carcinoma

EXPERIMENTAL

Tumor size \<5 cm (T1-2) and negative regional lymph nodes (N-) demonstrated by physical examination or contrast-enhanced pelvic MRI. After short-course radiotherapy, 4 cycles of albumin-bound paclitaxel plus platinum and sintilimab will be administered.

Drug: PD-1 Inhibitor + Chemotherapy

local resection of anal squamous cell carcinoma

EXPERIMENTAL

Inclusion criteria：no residual tumor visible on physical examination or imaging after local excision.Pathology after local excision reveals high-risk factors, positive margins, or unknown margins.Following short-course radiotherapy, 4 cycles of albumin-bound paclitaxel plus platinum and sintilimab will be administered.Primary endpoint: Severe acute toxicity.

Drug: PD-1 Inhibitor + Chemotherapy

Locally advanced anal squamous cell carcinoma

EXPERIMENTAL

Eligibility Criteria:Tumor ≥5 cm (T3) demonstrated by physical examination or contrast-enhanced pelvic MRI;or invasion of adjacent organs (T4);or regional lymph node positivity (N+) in the mesorectal, presacral, internal/external iliac, or inguinal lymph node regions. Treatment:Long-course radiotherapy at 54-56 Gy,concurrent with 2 cycles of albumin-bound paclitaxel plus platinum.After completion of radiotherapy,4 cycles of albumin-bound paclitaxel plus platinum and sintilimab will be administered. Primary Endpoint:Complete response rate (including cCR and pCR).

Drug: PD-1 Inhibitor + Chemotherapy

Recurrent and metastatic anal squamous cell carcinoma

EXPERIMENTAL

Eligibility Criteria:Initial distant metastasis (M1) in the liver, lung, bone, distant lymph nodes, or other sites confirmed by chest and abdominal CT or PET-CT;or pelvic recurrence after prior treatment, with or without distant metastasis. Treatment:Radiotherapy to recurrent or metastatic lesions, followed by chemotherapy combined with sintilimab. Primary Endpoint:12-month progression-free survival (PFS).

Drug: PD-1 Inhibitor + Chemotherapy

Interventions

PD-1 Inhibitor + Chemotherapy DRUG

chemotherapy and sintilimab

Also known as: radiotherapy

Early stage anal squamous cell carcinoma; Locally advanced anal squamous cell carcinoma; Recurrent and metastatic anal squamous cell carcinoma; local resection of anal squamous cell carcinoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with any of the following criteria are ineligible for this study:
• Pathological diagnosis of other anal tumors, such as gastrointestinal stromal tumor, lymphoma, melanoma, etc.; Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies; Previous or concurrent malignancy, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma; Active autoimmune disease or history of autoimmune disease (including but not limited to interstitial lung disease, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); excluding: autoimmune-mediated hypothyroidism on a stable dose of thyroid replacement therapy; type 1 diabetes mellitus on a stable dose of insulin; vitiligo; childhood asthma/allergy that resolved with no intervention required in adulthood; History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency disorders, history of organ transplantation or allogeneic bone marrow transplantation; History of interstitial lung disease (excluding radiation pneumonitis not requiring corticosteroid therapy) or non-infectious pneumonitis; Active pulmonary tuberculosis confirmed by medical history or CT scan, active tuberculosis within 1 year prior to enrollment, or inactive tuberculosis for more than 1 year without standard anti-tuberculosis treatment; Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or active hepatitis C (positive anti-HCV antibody with HCV RNA above the lower limit of detection); Severe cardiac, pulmonary, hepatic, or renal dysfunction; History of psychoactive substance abuse, alcoholism, or drug addiction; Any other conditions judged by the investigator that may compromise patient safety or study compliance, including severe medical or psychiatric disorders requiring concurrent treatment, significant laboratory abnormalities, or other social or family factors.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Immune Checkpoint Inhibitors; Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Model Details: chemoradiotherapy combined with immune checkpoint inhibitors in anal cancer.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 29, 2026
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CN (1)