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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05252078 on ClinicalTrials.gov