RecruitingPhase 2NCT05738434

Camrelizumab in Combination With Apatinib Mesylate Plus Short-course Chemotherapy for Advanced ESCC

A Randomized, Controlled, Multicenter Clinical Study of Camrelizumab in Combination With Apatinib Mesylate and Chemotherapy Versus Camrelizumab Plus Chemotherapy in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma


Sponsor

The First Affiliated Hospital of Zhengzhou University

Enrollment

188 participants

Start Date

Mar 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy and safety of patients with advanced esophageal squamous cell carcinoma treated with camrelizumab combined with Apatinib mesylate plus short-course chemotherapy versus standard chemotherapy in first line


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three treatments — camrelizumab (an immunotherapy), apatinib (a targeted therapy), and a shorter course of chemotherapy — for people with advanced or metastatic esophageal squamous cell cancer (a type of cancer in the food pipe) who have not previously received systemic treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have been confirmed to have esophageal squamous cell carcinoma that cannot be surgically removed, has returned, or has spread to other parts of the body - You have not previously had systemic cancer treatment (or your last chemotherapy was more than 6 months before relapse) - You have at least one measurable tumor site - You are in reasonably good health (ECOG performance status 0–1) - You can swallow pills normally and your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have other types of esophageal cancer (not squamous cell) - You have severe heart, liver, kidney, or immune-related conditions - You are pregnant or breastfeeding - You currently have or recently had serious infections 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

DRUGCamrelizumab+Apatinib+Chemotherapy→Camrelizumab+Apatinib

camrelizumab 200 mg, i.v. d1,q3w; apatinib 250 mg, p.o. qd,q3w; cisplatin 25 mg/m2, i.v. d1-d3,q3w; According to investigator' choice: paclitaxel 135\~150 mg/m2, i.v. d1,q3w; paclitaxel-albumin 150\~180 mg/m2, i.v. d1,q3w. up to 4 cycles and sequential maintenance therapy: camrelizumab 200 mg, i.v. d1,q3w; apatinib 250 mg, p.o. qd,q3w

DRUGCamrelizumab+Chemotherapy→Camrelizumab

camrelizumab 200 mg, i.v. d1,q3w; cisplatin 25 mg/m2, i.v. d1-d3,q3w; According to investgator' choice: paclitaxel 175 mg/m2, i.v. d1,q3w; paclitaxel-albumin 200 mg/m2, i.v. d1,q3w up to 6 cycles and sequential maintenance therapy: camrelizumab 200 mg, i.v. d1,q3w;


Locations(1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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NCT05738434