Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Experimental group in Cohort 1. TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin, 21 days as a treatment cycle. After 4\~6 cycles, TQB2618 injection combined Penpulimab injection, 21 days as a treatment cycle.

Active comparator group in Cohort 1. Penpulimab injection, Paclitaxel, Cisplatin, 21 days as a treatment cycle.

After 4\~6 cycles, Penpulimab injection 21 days as a treatment cycle.

Cohort 2. TQB2618 injection, Penpulimab injection, 21 days as a treatment cycle.

TQB3617 capsules are administered on Day 1 and Day 14, 21 days as a treatment cycle.

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.

TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin

Penpulimab injection：Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1).

Paclitaxel and Cisplatin are chemotherapy.

Penpulimab injection, Paclitaxel, Cisplatin

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

TQB2618 injection, Penpulimab injection, TQB3617capsules

Xianru Zhang, Master

Yiping Zhu, Doctor

Jie Shen, Doctor

Zhiye Zhang, Master

Yunfang Chen, Bachelor

Junye Wang, Bachelor

Jun Zhao, Doctor

Junyan Yu, Doctor

Yunxia Wang, Master

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).

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

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

The time from the first administration of the drug to disease progression or death (whichever occurs first).

According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST, the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment.

From randomization to the time of death from any cause.

The percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) at 6 weeks or greater than or equal to as determined by investigators according to Response evaluation criteria in solid tumors (RECIST) 1.1.

The period from firstly-recorded objective tumor response (CR or PR) to firstly-recorded objective tumor progression or death due to any cause (whichever occurs first).

All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug. The adverse events were evaluated according to the National Cancer Institute standard for common toxic reactions (NCI-CTC v5.0).

All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug. The severity of adverse events were evaluated according to the National Cancer Institute standard for common toxic reactions (NCI CTC) V5.0.

It refers to adverse medical events such as death, life-threatening, permanent or serious disability or loss of function, hospitalization or prolonged hospitalization, and congenital abnormalities or birth defects after the subject receives the experimental drug.

Spots Global Cancer Trial Database for penpulimab injection, paclitaxel, cisplatin