Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients

ConditionsEsophageal 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

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorJiangxi Provincial Cancer Hospital

About this trial

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).

Eligibility criteria

Qualifiers

Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.

≥ 18 years old.

ECOG performance status of 0-1

Patients with esophageal squamous cell carcinoma pathologically diagnosed as T1-2N1-3M0 or T3-4NanyM0.

Disqualifiers

Patients received other antitumor adjuvant therapy after surgical resection.

Concurrent malignancy (except cured basal cell carcinoma of the skin).

Patients was diagnosed cervical esophageal carcinoma.

Patients who have received prior targeted therapy (anti-VEGF/VEGFR) or immunity therapy (anti-PD-1/PD-L1/CTLA-4).

Trial design

Treatments tested in this trial

Anlotinib hydrochloride
TQB2450

Treatment groups

30 Participants

are divided into 1 treatment group

Sponsors and collaborators

Jiangxi Provincial Cancer Hospital

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Collaborator

Source ClinicalTrials.gov