MedTrace Logo

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

NCT05783921 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-07-28

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent Squamous Cell Carcinoma of the Head and Neck
  • Metastatic Squamous Cell Carcinoma

Interventions

DRUG

TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin

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.

DRUG

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.

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
2023-05-23
Primary Completion
2024-08-31
Completion
2025-01-31

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 NCT05783921 on ClinicalTrials.gov