Status:
NOT_YET_RECRUITING
Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Biliary Tract Cancer
Disitamab Vedotin
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This trial is a single-arm exploratory phase II clinical study initiated by the investigator. Subjects who met the research criteria were screened and enrolled to receive the treatment regimen of dis...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Participants who voluntarily participate in this study, sign the written informed consent, and are able to comply with the protocol.
- Age ≥ 18 years and any gender.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).
- At least one measurable lesion (according to RECIST 1.1).
- ECOG performance status score of 0-1.
- Child-Pugh score ≤ 7 .
- HER2 expression confirmed by: Immunohistochemistry (IHC 2+ or 3+); or Fluorescence in situ hybridization (FISH) with HER2/CEP17 ratio ≥2.0; or Next-generation sequencing (NGS) showing HER2 amplification.
- No prior HER2-targeted therapy (including antibody-based agents, small-molecule TKIs, or antibody-drug conjugates) before randomization.
- Expected survival \> 12 weeks.
- Adequate hematological and major organ function.
- Exclusion criteria：
- Histological or cytological diagnosis of combined hepatocellular-cholangiocarcinoma (cHCC-CCA), mucinous adenocarcinoma, sarcoma, or neuroendocrine tumors.
- Pregnant women (positive pregnancy test before medication) or lactating women.
- Known allergy or intolerance to disitamab vedotin, lenvatinib, PD-1 inhibitors, or their excipients.
- History of other active malignancies within 5 years prior to screening.
- Presence of central nervous system metastasis and/or leptomeningeal metastasis.
- Unhealed severe wounds, active ulcers, or untreated fractures.
- Administration of live vaccines within 30 days prior to randomization.
- Active autoimmune disease or history of autoimmune disease.
- Presence of clinically significant gastrointestinal disorders.
- Presence of clinically significant cardiovascular or cerebrovascular diseases.
Exclusion
Key Trial Info
Start Date :
August 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT07159217
Start Date
August 30 2025
End Date
May 31 2028
Last Update
September 8 2025
Active Locations (1)
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1
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Beijing, China