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

Sponsor
Sir Run Run Shaw Hospital
Study ID
NCT07514533
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vibecototamab（iv）+Putilimab（iv） — DRUG
    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.

Study Details

(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 Dates

First listed
Apr 7, 2026
Start date
Mar 11, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: pucotenlimab（iv）+ Becotatugvedotin（iv）

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 2 year ]

Central Contacts

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