Trials / Withdrawn
WithdrawnNCT04682249
Systemic Chemotherapy, Apatinib Plus Sintilimab for Metastasis ICC
Systemic Chemotherapy Based on Oxaliplatin and 5-fluorouracil, Apatinib Plus Sintilimab for Metastasis ICC: a Single Arm Prospective Study
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study were designed to verify the better method of survival for metastatic ICC. Since the traditional method for metastatic ICC was GEMOX(first-line treatment from NCCN guideline), our previous study found similar results from FOLFOX (second-line treatment from NCCN guideline) compared with GEMOX. Our current study were conducted for further investigation to verify the better method for metastatic ICC.
Detailed description
ICC(Intrahepatic CholangioCarcinoma) patients with metastasis has a short survival time and poor prognosis after diagnosis. Treatment methods was few and far from satisfaction. The treatment recommended from NCCN guideline was GEMOX(Systemic Chemotheray) and clinical trials. Our previous study has demonstrate FOLFOX (Systemic Chemotheray based on Oxaliplatin#5- fluorouracil) has a similar survival and tumor response compared with GEMOX. Further study was needed to intensive confirmation of the result. We designed this study to demonstrate the hypothesis. Metastasis ICCs were recruited and screened by our criteria. All patients were treated with FOLFOX (Systemic Chemotheray based on Oxaliplatin#5-fluorouracil ), apatinib (one of tyrosine kinase inhibitors) plus sintilimab (one of PD-1 antibody). Our study were designed to verify the better method of survival for metastatic ICC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Systemic Chemotherapy | Systemic Chemotherapy (Oxaliplatin#5-fluorouracil and leucovorin) |
| DRUG | Sintilimab | Sintilimab |
| DRUG | Apatinib | Apatinib |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2021-02-01
- Completion
- 2021-02-01
- First posted
- 2020-12-23
- Last updated
- 2021-02-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04682249. Inclusion in this directory is not an endorsement.