Biliary Tract Cancer, Disitamab Vedotin, Immune Checkpoint Inhibitors, Lenvatinib
Conditions
Keywords
Biliary tract cancer, Disitamab vedotin, Lenvatinib, Immune checkpoint inhibitors
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 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.
Interventions
DRUGDisitamab Vedotin
2.0 mg/kg administered intravenously every three weeks
DRUGLenvatinib
≥60 kg: 12 mg once daily, or \<60 kg: 8 mg once daily
DRUGPembrolizumab
200 mg intravenously every three weeks
DRUGToripalimab
240 mg intravenously every three weeks
DRUGCamrelizumab
200 mg intravenously every three weeks
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants who voluntarily participate in this study, sign the written informed consent, and are able to comply with the protocol. 2. Age ≥ 18 years and any gender. 3. Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC). 4. At least one measurable lesion (according to RECIST 1.1). 5. ECOG performance status score of 0-1. 6. Child-Pugh score ≤ 7 . 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. 8. No prior HER2-targeted therapy (including antibody-based agents, small-molecule TKIs, or antibody-drug conjugates) before randomization. 9. Expected survival \> 12 weeks. 10. Adequate hematological and major organ function.
Exclusion criteria
： 1. Histological or cytological diagnosis of combined hepatocellular-cholangiocarcinoma (cHCC-CCA), mucinous adenocarcinoma, sarcoma, or neuroendocrine tumors. 2. Pregnant women (positive pregnancy test before medication) or lactating women. 3. Known allergy or intolerance to disitamab vedotin, lenvatinib, PD-1 inhibitors, or their excipients. 4. History of other active malignancies within 5 years prior to screening. 5. Presence of central nervous system metastasis and/or leptomeningeal metastasis. 6. Unhealed severe wounds, active ulcers, or untreated fractures. 7. Administration of live vaccines within 30 days prior to randomization. 8. Active autoimmune disease or history of autoimmune disease. 9. Presence of clinically significant gastrointestinal disorders. 10. Presence of clinically significant cardiovascular or cerebrovascular diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR, objective response rate | 12 months after the last subject is enrolled |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS, progression free survival | 12 months after the last subject is enrolled | — |
| OS, overall survival | 12 months after the last subject is enrolled | — |
| DCR, disease control rate | 12 months after the last subject is enrolled | — |
| DoR, duration of response | 12 months after the last subject is enrolled | — |
| Adverse events (AE) and serious adverse events (SAE) | 12 months after the last subject is enrolled | To evaluate safety, incidence and outcome of adverse events (AE), and serious adverse events (SAE) |
Countries
China
Contacts
Primary ContactShuofeng Li
Outcome results
None listed