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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
Phase 2 trial testing Serplulimab in Cervical Cancer in 48 participants. Status unknown.
30 September 2024
Quick facts
| Lead sponsor | Sichuan Cancer Hospital and Research Institute |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 1 October 2022 |
| Primary completion | 30 September 2024 |
| Estimated completion | 31 December 2025 |
| Sites | 4 locations across China |
Drugs / interventions tested
- Serplulimab — full drug profile →
- Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
Conditions studied
- Cervical Cancer — all drugs for Cervical Cancer →
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):
-
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 -
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 -
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:
- PubMed search for NCT05444374
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07381400 — Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Stu · Phase 2 · not yet recruiting
- NCT07269782 — A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCL · Phase 2 · recruiting
Other recruiting trials for Cervical Cancer
Currently open trials in the same condition.
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- NCT07256236 — SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer · Phase 2 · recruiting
Other Sichuan Cancer Hospital and Research Institute trials
Trials by the same sponsor.
- NCT07269912 — Application of Multimodal MRI in Histological Grading and Prognostic Assessment of Rectal Cancer · not yet recruiting
- NCT07082699 — The Efficacy of Antegrade and Retrograde Enemas Management in Low Anterior Resection Syndrome and Improving the Rate of · NA · not yet recruiting
- NCT06939764 — Application of the sG8 Scale in Real-World Geriatric Oncology Patients · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05444374 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sichuan Cancer Hospital and Research Institute
- Last refreshed: 5 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05444374.
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