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Clinical Trial to Evaluate the Safety and Effectiveness of TQB2618 Injection Combined Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma

NCT05834543 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-07-16

No results posted yet for this study

Summary

To investigate the efficacy and safety of TQB2618 injection combined Penpulimab and chemotherapy in the first-line treatment of recurrent/metastatic esophageal squamous cell carcinoma compared with Penpulimab combined chemotherapy.

The primary efficacy outcomes are progression free survival (PFS) and objective response rate (ORR).

Conditions

  • Advanced Esophageal Squamous Cell Carcinoma

Interventions

DRUG

TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin

TQB2618 injection：Anti-TIM-3 monoclonal antibody. Penpulimab injection：Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1). Paclitaxel and Cisplatin are chemotherapy.

DRUG

Penpulimab injection, Paclitaxel, Cisplatin

Penpulimab injection：Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1). Paclitaxel and Cisplatin are chemotherapy.

DRUG

TQB2618 injection, Penpulimab injection, TQB3617capsules

TQB2618 injection：Anti-TIM-3 monoclonal antibody. Penpulimab injection：Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1).

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-26
Primary Completion
2024-10-23
Completion
2025-03-03

Countries

  • China

Study Locations

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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 NCT05834543 on ClinicalTrials.gov