A Trial of TQB2868 Plus Platinum-based Chemotherapy With or Without Bevacizumab in the First-line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT05998941
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TQB2868 injection — DRUG
    TQB2868 injection is an anti-programmed cell death protein 1 (PD-1)/ transforming growth factor-β (TGF-β) dual-function fusion protein.
  • Paclitaxel injection — DRUG
    Paclitaxel injection prevents depolymerization of microtubules, inhibits mitosis, and hinders normal cell division.
  • Cisplatin injection — DRUG
    Cisplatin injection can inhibit the DNA replication process of cancer cells
  • Carboplatin injection — DRUG
    Carboplatin injection acts directly on DNA, thus inhibiting the vigorous division of tumor cells.
  • Bevacizumab injection — DRUG
    Bevacizumab is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF).

Study Details

This study used a single-arm, open phase II multicenter trial design. All eligible subjects received TQB2868 plus platinum-based chemotherapy with or without bevacizumab. A total of 39 subjects will be enrolled.

Key Dates

First listed
Aug 21, 2023
Start date
Aug 31, 2023
Status verified
Nov 2023
Primary completion
Feb 28, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection
    TQB2868 injection + paclitaxel injection + cisplatin/carboplatin injection ± bevacizumab injection, 3 weeks (21 days) as a treatment cycle.

Primary Outcome Measure

Investigator-assessed objective response rate (ORR) [ Time Frame: Baseline to CR or PR ,about 12 months ]

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