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.
Aged between 18 and 75 years, male or female;
Voluntarily signed the informed consent form and is willing to comply with protocol-specified requirements;
Histologically confirmed locally advanced anal squamous cell carcinoma of cT2-4N0-1M0 stage;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Diagnosis of another malignancy within the past 5 years (excluding concurrent CIN2+ or cervical cancer; in-situ carcinomas and basal-cell carcinomas outside the pelvic region are permitted).
Pre-existing peripheral neuropathy ≥ Grade 2 (per CTCAE Version 5.0).
Patients planning to undergo or having previously received organ or bone-marrow transplantation.
Any major surgery within 4 weeks prior to the first study treatment (diagnostic biopsy excluded).
Single group
Induction therapy
DrugPatients 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.
Concurrent chemoradiotherapy-immunotherapy
RadiationFollowing 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.
Maintenance therapy
DrugAfter completion of concurrent chemoradiotherapy-immunotherapy, patients receive pucotenlimab (200 mg intravenously) every 3 weeks for up to 1 year as maintenance treatment.
The Complete response (CR) rate at 40 weeks
The CR rate at 40 weeks is defined as the number of patients who have no residual or metabolically active local tumour identified by digital rectal examination, colonoscopy with pathological assessment, and MRI, plus no distant metastasis confirmed by thoracic-abdominal CT at 40 weeks, divided by the total number of patients evaluable for CR status at 40 weeks.
Safety
Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0, vital signs, and clinical laboratory test results in the Safety Analysis Set
Objective Response Rate (ORR)
The ORR is defined as the proportion of subjects achieving a complete response or partial response after completion of 2 cycles of induction therapy and prior to the initiation of concurrent chemoradiotherapy-immunotherapy.
Disease Control Rate (DCR)
The DCR is defined as the proportion of subjects achieving a complete response, partial response, or stable disease upon completion of induction therapy.
Event-free survival (EFS)
The EFS is defined as the time from the first study-drug administration to the earliest occurrence of disease progression, recurrence, initiation of new therapy, or death.
Overall Survival（OS）
The OS is defined as the time from the first study-drug administration to death from any cause.
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Wang Xin
Lead sponsor
West China Hospital
Sponsor institution
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