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NOT YET RECRUITING
NCT07514533
PHASE2

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

Sponsor: Sir Run Run Shaw Hospital

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-03-11

Completion Date

2027-12-31

Last Updated

2026-04-07

Healthy Volunteers

No

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.