Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Cisplatin

Immunoglobulins

Immunoglobulins, Intravenous

Tubulin Modulators

Antimitotic Agents

TQB2618 injection combined with Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin, 21 days as a treatment cycle. After 4\~6 cycles, TQB2618 injection combined with Penpulimab injection, 21 days as a treatment cycle.

Penpulimab injection combined with Paclitaxel, Cisplatin or Carboplatin, 21 days as a treatment cycle. After 4\~6 cycles, Penpulimab injection, 21 days as a treatment cycle.

TQB2618 injection is an Anti TIM-3 (T-cell immunoglobulin and mucin domain-3) monoclonal antibody.

Penpulimab injection is a humanized Monoclonal Antibody target Programmed Cell Death Protein 1 (PD-1).

Paclitaxel is a anti-microtubule drug, which promotes tubulin polymerization, inhibits depolymerization, maintains tubulin stability and inhibits cell mitosis.

Cisplatin inhibits DNA synthesis by generating in-strand interstrand crosslinking with DNA. Protein and RNA synthesis can also be inhibited.

Carboplatin is a cyclic nonspecific antitumor agents that cause cross-linking between DNA strands and affect their synthesis to inhibit cancer cells.

TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin

Penpulimab injection is a humanized Monoclonal Antibody target Programmed Cell Death Protein 1 (PD-1).

Paclitaxel is a anti-microtubule drug, which promotes tubulin polymerization, inhibits depolymerization, maintains tubulin stability and inhibits cell mitosis.

Cisplatin inhibits DNA synthesis by generating in-strand interstrand crosslinking with DNA. Protein and RNA synthesis can also be inhibited.

Carboplatin is a cyclic nonspecific antitumor agents that cause cross-linking between DNA strands and affect their synthesis to inhibit cancer cells.

Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin

Jun Wang

Fangming Li

Song Qu, Doctor

Jin Wu

YongGui Hong

Zhiye Zhang

Hong Zong, Doctor

Yunfang Chen

Yaqian Han

Jingao Li, Doctor

Zhendong Li, Doctor

XiuHua Sun

To evaluate the efficacy and safety of TQB2618 injection combined with Penpulimab and chemotherapy in the first-line treatment of relapsed/metastatic head and neck squamous cell carcinoma compared to Penpulimab combined chemotherapy.

Progression-free survival (PFS) and objective response rate (ORR) were the primary efficacy endpoints.

A Clinical Trial of TQB2618 Injection Combined With Penpulimab Injection and Chemotherapy Versus Penpulimab Injection Combined With Chemotherapy in First-line Treatment of Relapsed/Metastatic Head and Neck Squamous Cell Carcinoma

A Randomized, Open, Multicenter Phase 1/Phase 2 Clinical Trial of TQB2618 Injection Combined With Penpulimab Injection and Chemotherapy Versus Penpulimab Injection Combined With Chemotherapy in First-line Treatment of Relapsed/Metastatic Head and Neck Squamous Cell Carcinoma

The time period from the first administration of the drug to disease progression or death event (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 administration of the drug to disease progression or initiation of a new anticancer treatment.

Proportion of survived participants without progression at 9th months.

Time from the randomization to death from all causes.

The percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) for 6 weeks or more as determined by investigators according to RECIST 1.1.

The percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) for 6 months or more as determined by investigators according to 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, evaluated according to the National Cancer Institute standard for common toxic criteria \[NCI-CTC v5.0\].

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, 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 tqb2618 injection, penpulimab injection, paclitaxel, cisplatin or carboplatin