RecruitingPhase 2NCT05252078

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


Sponsor

Jiangxi Provincial Cancer Hospital

Enrollment

30 participants

Start Date

Jun 2, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two anti-cancer drugs — anlotinib (a targeted therapy that cuts off a tumor's blood supply) and TQB2450 (an immunotherapy drug) — can help prevent esophageal squamous cell cancer from coming back after surgery. The treatment is given as a maintenance therapy after a successful operation. **You may be eligible if...** - You are 18 or older - You have confirmed esophageal squamous cell carcinoma that was fully removed with surgery (R0 resection) - Imaging shows no signs of cancer return 6-12 weeks after surgery - Your cancer was at an intermediate or advanced stage (T1-2 with lymph node involvement, or T3-4) - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - You have received other anti-cancer treatments after your surgery - You have another active cancer (with minor exceptions) - Your cancer was in the uppermost part of the esophagus (cervical esophagus) - You have previously received targeted therapy or immunotherapy for esophageal cancer - You are allergic to the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnlotinib 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.

DRUGTQB2450

TQB2450 is an injection in the form of 600 mg; 1200 mg, iv, D1.


Locations(1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

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NCT05252078


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