Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients
NCT05252078 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2022-12-16
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).
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
- 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.
Sponsors & Collaborators
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
collaborator INDUSTRY -
Jiangxi Provincial Cancer Hospital
lead OTHER
Principal Investigators
-
Changying Guo, PhD · Jiangxi Provincial Cancer Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-02
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
Countries
- China
Study Locations
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