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The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma

NCT07514533 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-07

No results posted yet for this study

Summary

(1) Primary efficacy endpoint: Objective Response Rate (ORR) after 2 treatment cycles. ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) among all subjects. (2) Secondary efficacy endpoints include Progression-Free Survival (PFS), 2-year Relapse-Free Survival Rate, Disease Control Rate (DCR), Duration of Response (DOR), Adverse Reaction Incidence, 1-year Overall Survival Rate, 2-year Overall Survival Rate. Safety assessment includes physical examination, physical condition assessment (based on ECOG score), clinical laboratory tests and concomitant medication status. All observed drug toxicities and side effects need to be classified according to NCICTCAE and evaluated for their correlation with the drug. Patient Quality of Life (QoL) assessment uses the EORTC QLQC30 questionnaire and the BIL21 questionnaire. Recurrence patterns are classified as local recurrence and distant recurrence. Local control status is defined as the local failure rate (occurrence of local recurrence or local lymph node metastasis).

Conditions

Interventions

DRUG

Vibecototamab（iv）+Putilimab（iv）

1. Becotatugvedotin: 2mg/kg, intravenous, every 3 weeks, on day 1 2. pucotenlimab： 200mg, intravenous, every 3 weeks, on day 1 During administration, the pucotenlimab infusion should be completed at least 30 minutes before starting the Becotatugvedotin administration, via intravenous drip (60±10 minutes, the administration time for the first cycle should be ≥ 60 minutes). For patients who cannot tolerate the 60-minute infusion, the infusion time can be appropriately extended to 120 minutes. During the maintenance treatment phase, if any of the drugs is intolerable, another drug can be used for maintenance treatment. The investigator will assess whether to resume the medication based on the patient's recovery status. After 3-4 weeks after 3 courses, a re-examination and assessment will be conducted. For CR, PR, and SD, direct surgery will be performed. If PD, surgery or termination of the trial will be carried out.

Sponsors & Collaborators

  • Sir Run Run Shaw Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-11
Primary Completion
2027-12-31
Completion
2027-12-31

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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 NCT07514533 on ClinicalTrials.gov