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NCT05444374

A Phase II Study of Serplulimab Plus Bevacizumab in Combination With Chemotherapy in 1L Treatment of Untreated Recurrent or Metastatic Cervical Cancer

Status unknown Phase 2 Last updated 5 July 2022
What this trial tests

Phase 2 trial testing Serplulimab in Cervical Cancer in 48 participants. Status unknown.

Timeline
1 October 2022
Primary endpoint
30 September 2024
31 December 2025

Quick facts

Lead sponsorSichuan Cancer Hospital and Research Institute
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment48
Start date1 October 2022
Primary completion30 September 2024
Estimated completion31 December 2025
Sites4 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Sichuan Cancer Hospital and Research Institute

Who can join

Adults 18 to 75, female only, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a single-arm, multicenter, Phase II study to evaluate the efficacy and safety of the treatment of Serplulimab plus Bevacizumab in combination with chemotherapy in 1L treatment of patients with untreated recurrent or metastatic cervical cancer. Approximately 48 eligible subjects are planned to be enrolled across all sites. The dosing regimen is: Serplulimab plus Bevacizumab combined with chemotherapy (cisplatin, paclitaxel). Each cycle is 21 days (every 3 weeks). Subjects will receive Cisplatin plus Paclitaxel up to 4-6 cycles. The maximum duration of treatment with Serplulimab is 2 years (up to 35 cycles). During the study treatment period, the subjects will receive imaging examination and response assessments every 6 weeks (± 7 days) in the first 48 weeks, every 9 weeks (± 7 days) in 48-96 weeks, and then every 12 weeks (± 7 days). After the treatment discontinuation visit, the subjects will enter the safety follow-up period and survival follow-up period.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The anti-PD-1 era of cervical cancer: achievement, opportunity, and challenge.
    Li C, Cang W, Gu Y, Chen L, et al · · 2023 · cited 19× · PMID 37559727 · DOI 10.3389/fimmu.2023.1195476
  2. Efficacy and safety of serplulimab plus nab-paclitaxel in previously treated patients with PD-L1-positive advanced cervical cancer: a phase II, single-arm study.
    An J, Li X, Wang J, Zhu L, et al · · 2023 · cited 13× · PMID 37153587 · DOI 10.3389/fimmu.2023.1142256
  3. Immune checkpoint inhibitors in gynecologic oncology: Current status and perspectives.
    Yanaihara N, Tse KY, Lee SJ, Yoo JG, et al · · 2025 · cited 4× · PMID 40908776 · DOI 10.1002/ijgo.70280

Verify or expand the search:

Other trials of Serplulimab

Trials testing the same drug.

Other recruiting trials for Cervical Cancer

Currently open trials in the same condition.

Other Sichuan Cancer Hospital and Research Institute trials

Trials by the same sponsor.

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Data sources for this page

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