MedTrace Logo

A Phase III Study of First-line Anlotinib Combined With Benmelstobart in Patients With Advanced Esophageal Squamous Cell Carcinoma

NCT07446335 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 578

Last updated 2026-03-03

No results posted yet for this study

Summary

A Randomized, Open-Label, Parallel-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Safety and Efficacy of Anlotinib Hydrochloride Combined with Benmelstobart versus Toripalimab Combined with Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma Harboring Specific Gene Mutations

Conditions

  • Advanced Esophageal Squamous Cell Carcinoma

Interventions

DRUG

anlotinib combined with benmelstobart

Benmelstobart injection 1200 mg will be diluted in 250 mL normal saline (0.9% sodium chloride) and administered via intravenous infusion over 60 ± 10 minutes on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or a maximum of 24 months. Anlotinib hydrochloride capsules 12 mg will be administered orally once daily before breakfast at approximately the same time each day on a schedule of 2 weeks on and 1 week off in 21-day cycles until disease progression or unacceptable toxicity.

DRUG

Toripalimab Combined with Chemotherapy

Induction Phase (maximum 6 cycles):Toripalimab injection 240 mg will be administered intravenously over 60 minutes on Day 1 of each 21-day cycle after dilution in 100 mL normal saline (0.9% sodium chloride). Chemotherapy regimen will be determined prior to randomization based on individual patient characteristics. Patients will receive one of the following chemotherapy regimens per local treatment standards: Cisplatin 60-75 mg/m² intravenously on Day 1 plus paclitaxel 150-175 mg/m² intravenously over \>3 hours, both administered every 3 weeks; or cisplatin 60-75 mg/m² intravenously on Day 1 plus fluorouracil 700-850 mg/m² daily by continuous intravenous infusion over 24 hours on Days 1-5, repeated every 3 weeks. Maintenance Phase :Toripalimab injection 240 mg will be administered intravenously over 60 minutes on Day 1 of each 21-day cycle after dilution in 100 mL normal saline (0.9% sodium chloride).

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-12-31
Completion
2029-06-30

Countries

  • China

Study Locations

More Related Trials

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 NCT07446335 on ClinicalTrials.gov