Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHuiKai Li
About this trial
Biliary tract carcinoma (BTC), including cholangiocarcinoma and gallbladder cancer, is a highly aggressive digestive system malignancy with limited treatment options after failure of first-line standard chemotherapy.
This open-label, single-arm, Phase II exploratory study aims to evaluate the efficacy and safety of Becotatug Vedotin combined with Pucotenlimab in patients with EGFR-positive advanced BTC who have failed first-line therapy. Participants will receive the combination regimen until the occurrence of disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator's decision to discontinue treatment, or study termination, whichever occurs first.The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety.
Eligibility criteria
Qualifiers
Age ≥ 18 years, male or female.
Histologically or cytologically confirmed advanced biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC); recurrent biliary tract cancer is also eligible.
EGFR expression positive by immunohistochemistry (IHC) (+, ++, or +++).
Failed at least one line of standard systemic therapy.
Disqualifiers
Diagnosis of another primary malignancy within 5 years prior to enrollment, except for adequately treated carcinoma in situ or basal cell carcinoma of the skin.
EGFR expression negative by IHC.
Known central nervous system (CNS) metastases or carcinomatous meningitis, unless clinically stable for ≥ 4 weeks after radiotherapy or surgery and asymptomatic.
Psychiatric or neurological disorders that compromise the ability to comply with study procedures.
Trial design
Treatments tested in this trial
- Becotatug Vedotin
- Pucotenlimab
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
HuiKai Li
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Sponsor institution
Source ClinicalTrials.gov