Trials / Unknown
UnknownNCT05913661
Pemigatinib Combined With PD-1 Inhibitor in Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
Prospective, Single-arm, Multicenter Phase II Study of Evaluation of the Efficacy and Safety of Pemigatinib Combined With PD-1 Inhibitor in First-line Treatment of Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Prospective, single-arm, phase II study with multicenter participation. The objective of this study is to evaluate the efficacy and safety of pemigatinib combined with PD-1 inhibitor as first-line treatment for patients with advanced unresectable or metastatic intrahepatic cholangiocarcinoma.
Detailed description
The study will be divided into two phases. The first phase is the safety import phase, in which three subjects with intrahepatic cholangiocarcinoma will be enrolled to receive a Scheduled dose of pemigatinib for one course of treatment， If the initial three subjects didn't develop DLT during the 21-day observation period, the dose will be considered tolerable and the study will proceed to Part II, otherwise, the dose will be adjusted and the evaluation will continue according to the above criteria. A total of 30 subjects will be enrolled in Phase II of the study, and all screening-qualified subjects will receive pemigatinib combined with PD-1 inhibitor. pemigatinib and PD-1 inhibitors will be administered at established doses according to a regimen until progressive disease, intolerable toxicity, or informed consent form has been withdrawn. PD-1 inhibitors will be administered for a maximum of 24 months.
Conditions
- Carcinoma
- Intrahepatic Cholangiocarcinoma
- Digestive System Neoplasms
- PD-1 Inhibitor
- First-line Treatment
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pemigatinib | Pemigatinib is scheduled to be administered at a dose of 13.5 mg quaque die according to a 2-week dosing and 1-week discontinuation regimen. |
| DRUG | PD-1 Inhibitors | The dosing regimen is 200 mg IV Q3W |
Timeline
- Start date
- 2023-07-01
- Primary completion
- 2024-11-01
- Completion
- 2024-11-01
- First posted
- 2023-06-22
- Last updated
- 2023-06-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05913661. Inclusion in this directory is not an endorsement.