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Becotatug Vedotin Plus Pucotenlimab and Capecitabine Followed by Concurrent Chemoradiotherapy-Immunotherapy for Locally Advanced Squamous Cell Carcinoma of the Anal Canal

NCT07800000 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-09-02

No results posted yet for this study

Summary

This is a single-arm, exploratory clinical study intended to enroll patients with EGFR-positive Locally Advanced Squamous Cell Carcinoma of the Anal Canal (T2-4N0-1M0). Patients will first receive 2 cycles of induction therapy consisting of Becotatug Vedotin combined with Pucotenlimab and Capecitabine. Patients without disease progression upon radiological assessment will subsequently proceed to the concurrent chemoradiotherapy-immunotherapy phase, which comprises Capecitabine plus Pucotenlimab and mitomycin-C together with definitive concurrent radiotherapy. In the subsequent maintenance phase, patients will receive Pucotenlimab for a total duration of 1 year. The study aims to evaluate the efficacy and safety of Becotatug Vedotin combined with Pucotenlimab and Capecitabine, as well as the potential of this novel full-course treatment paradigm.

Conditions

Interventions

DRUG

Induction therapy

Patients receive becotatug vedotin (2.0 mg/kg intravenously on Day 1) plus pucotenlimab (200 mg intravenously on Day 1) and capecitabine (1000 mg/m² orally twice daily) every 3 weeks for 2 consecutive cycles.

RADIATION

Concurrent chemoradiotherapy-immunotherapy

Following induction therapy, patients without disease progression receive capecitabine (825 mg/m² orally twice daily) combined with pucotenlimab (200 mg intravenously on Day 1) and mitomycin-C (10 mg/m² intravenously on Day 1 and Day 28), administered in parallel with definitive pelvic radiotherapy. Radiotherapy doses were prescribed following NCCN, ESTRO and EORTC guideline recommendations.

DRUG

Maintenance therapy

After completion of concurrent chemoradiotherapy-immunotherapy, patients receive pucotenlimab (200 mg intravenously) every 3 weeks for up to 1 year as maintenance treatment.

Sponsors & Collaborators

  • Wang Xin

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-20
Primary Completion
2028-09-19
Completion
2029-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07800000 on ClinicalTrials.gov