Trials / Completed
CompletedNCT04642664
Apatinib Plus Camrelizumab in Patients With Previously Treated Advanced Biliary Tract Cancer
Apatinib Plus Camrelizumab in Patients With Previously Treated Advanced Biliary Tract Cancer (ACABC): A Prospective Clinical Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Peking Union Medical College Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The investigators design a prospective clinical study to explore the efficacy and safety of apatinib plus camrelizumab in pretreated patients with advanced biliary tract malignant tumors and to analyze potential biomarkers of therapeutic response.
Detailed description
This was a non-randomized, single institutional, open-label, prospective trial designed to evaluate the efficacy and safety of apatinib in combination with camrelizumab for patients with biliary tract malignant tumors. It is estimated that 20 patients who met the study criteria will be enrolled in PUMCH and treated with aptinib and camrelizumab. The investigators will follow up and collect subjects' data each month to evaluate the efficacy and safety of treatment, including treatment related adverse events, overall survival and time to progression and objective response. Multi-omics data analysis will be used to find potential biomarkers of treatment response.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apatinib plus Camrelizumab | Patients received apatinib orally at 250 mg once a day irrespective of the patient weight. During the treatment, apatinib can reduced to half of piece or once every other day considering the grade of treatment related adverse events. Camrelizumab 200 mg was administered intravenously over 30 minutes every 3 weeks. The intermittent period of camrelizumab was no longer than 6 weeks. All patients continued combination treatment until disease progression, unacceptable toxicity, or discontinuation for any reason. |
Timeline
- Start date
- 2018-12-01
- Primary completion
- 2020-12-01
- Completion
- 2021-01-01
- First posted
- 2020-11-24
- Last updated
- 2021-06-03
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04642664. Inclusion in this directory is not an endorsement.