Trials / Unknown
UnknownNCT04229849
Anrotenib Plus Toripalimab Versus Toripalimab in Patients With Advanced Esophageal Squamous Cell Carcinoma
A Randomized, Open-label, Controlled, Multicenter Phase II Trial of Anrotenib Plus Toripalimab Versus Toripalimab for Following Treatment of Advanced Esophageal Squamous Cell Carcinoma After Chemotherapy Failure
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 164 (estimated)
- Sponsor
- Henan Cancer Hospital · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to investigate the efficacy and safety of anrotenib plus toripalimab in the treatment of advanced esophageal squamous cell carcinoma. In addition, the investigators will explore the possible mechanisms of anrotinib combined with toripalimab in advanced esophageal squamous cell carcinoma, and screen out biomarkers that can predict the efficacy of combination therapy.
Detailed description
There is no standard recommendation for the treatment of advanced esophageal squamous cell cancer after chemotherapy failure. Anrotinib combined with triplizumab have showed synergistic effect in the tumor treatment, and they have demonstrated robust antitumor activity in the first-line treatment of advanced NSCLC with negative driving gene. However, there is no related report on the efficacy in the treatment of advanced esophageal squamous cell carcinoma. The aim of this study is to investigate the efficacy and safety of anrotenib plus toripalimab in the treatment of advanced esophageal squamous cell carcinoma. In addition, the investigators will explore the possible mechanisms of anrotinib combined with toripalimab in advanced esophageal squamous cell carcinoma, and screen out biomarkers that can predict the efficacy of combination therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anrotenib plus Toripalimab | Anrotenib: 10 mg on day 1-14 orally repeated every 21 days; Toripalimab: 240 mg on day 1 intravenously repeated every 21 days. |
| DRUG | Toripalimab | Toripalimab: 240 mg on day 1 intravenously repeated every 21 days. |
Timeline
- Start date
- 2020-01-01
- Primary completion
- 2021-01-01
- Completion
- 2022-01-01
- First posted
- 2020-01-18
- Last updated
- 2020-01-18
Source: ClinicalTrials.gov record NCT04229849. Inclusion in this directory is not an endorsement.