Trials / Recruiting
RecruitingNCT05252078
Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients
An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients as Postoperative Adjuvant Therapy
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Jiangxi Provincial Cancer Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma (ESCC) Patients as Postoperative Adjuvant Therapy. In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection in treatment of patients with ESCC. The primary endpoint is disease free survival (DFS).
Detailed description
This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma (ESCC) Patients as Postoperative Adjuvant Therapy. In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection in treatment of patients with Esophageal Squamous Cell Carcinoma (ESCC). Primary Efficacy Endpoint: Disease Free Survival (DFS) (According to RECIST Version 1.1), Secondary Efficacy Endpoints:1-year DFS rate, 3-year DFS rate, 1-year Overall Survival (OS) rate, 3-year OS rate, and Safety. Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 5.0.
Conditions
- Esophageal Squamous Cell Carcinoma
- Esophageal Neoplasms
- Esophageal Diseases
- Gastrointestinal Neoplasms
- Gastrointestinal Diseases
- Digestive System Neoplasms
- Digestive System Diseases
- Neoplasms by Site
- Neoplasms by Histologic Type
- Neoplasms, Squamous Cell
- Carcinoma, Squamous Cell
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anlotinib hydrochloride | Anlotinib Hydrochloride is a capsule in the form of 8 mg ,10 mg and 12 mg, orally, once daily, 2 weeks on/1 week off. |
| DRUG | TQB2450 | TQB2450 is an injection in the form of 600 mg; 1200 mg, iv, D1. |
Timeline
- Start date
- 2022-06-02
- Primary completion
- 2026-11-01
- Completion
- 2026-11-01
- First posted
- 2022-02-23
- Last updated
- 2022-12-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05252078. Inclusion in this directory is not an endorsement.