Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer

ConditionsBiliary Tract Cancer Disitamab Vedotin Lenvatinib Immune Checkpoint Inhibitors

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Disitamab Vedotin
Drug
2.0 mg/kg administered intravenously every three weeks
Lenvatinib
Drug
≥60 kg: 12 mg once daily, or \<60 kg: 8 mg once daily
Pembrolizumab
Drug
200 mg intravenously every three weeks
Toripalimab
Drug
240 mg intravenously every three weeks
Camrelizumab
Drug
200 mg intravenously every three weeks

Treatment groups

65 Participants

are divided into 1 treatment group

Group A: Disitamab vedotin combined with lenvatinib and PD-1 inhibitorExperimental treatment 5 interventions