NCT07159217Not yet recruitingPhase 2
Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer
A Prospective Exploratory Phase II Study of Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for the Treatment of HER2-positive Advanced Biliary Tract Cancer
Source: ClinicalTrials.gov · Last updated 8 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 disitamab vedotin combined with lenvatinib and PD-1 inhibitor. During the treatment process, the researchers closely followed up, strictly evaluated the efficacy, assessed the efficacy and safety of the subjects after receiving the combined treatment, evaluated the subjects until progression occurred, and observed their objective response rate, progression-free survival, overall survival, disease control rate, duration of response, and safety evaluation.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 18 Aug 2025
- Start date
- 30 Aug 2025
- Primary completion date
- 31 May 2027
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07159217
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 65
- From 30 Aug 2025 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnant women (positive pregnancy test before medication) or lactating women.
- History of other active malignancies within 5 years prior to screening.
- Administration of live vaccines within 30 days prior to randomization.
Other illness
- Known allergy or intolerance to disitamab vedotin, lenvatinib, PD-1 inhibitors, or their excipients.
- Active autoimmune disease or history of autoimmune disease.
- Presence of clinically significant gastrointestinal disorders.
- Presence of clinically significant cardiovascular or cerebrovascular diseases.
Other
- Histological or cytological diagnosis of combined hepatocellular-cholangiocarcinoma (cHCC-CCA), mucinous adenocarcinoma, sarcoma, or neuroendocrine tumors.
- Presence of central nervous system metastasis and/or leptomeningeal metastasis.
- Unhealed severe wounds, active ulcers, or untreated fractures.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese Academy of Medical Sciences & Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.