NCT05872724

Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD(Minimal Residual Disease)

Recruiting now Phase 2 Last updated 24 May 2023

What this trial tests

Phase 2 trial testing Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab in Cervical Cancer in 32 participants. Currently enrolling.

Timeline

16 January 2023

Primary endpoint
16 January 2028

30 December 2028

Quick facts

Lead sponsor	Suzhou Municipal Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	16 January 2023
Primary completion	16 January 2028
Estimated completion	30 December 2028
Sites	1 location across China

Drugs / interventions tested

• Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab — full drug profile →
• Chemoradiotherapy (small pelvic) + Zimberelimab — full drug profile →

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →

Sponsor

Suzhou Municipal Hospital

Who can join

18 and older, female only, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a prospective cohort clinical trial that aims to investigate the safety and efficacy of a combined chemoradiotherapy and immunotherapy treatment for early postoperative cervical cancer. Specifically, this study seeks to evaluate the ability of MRD-based screening to detect and monitor changes in MRD status at different stages of treatment, its potential for use in monitoring patient recurrence rates and in prognosis evaluation. In addition, this study will investigate the safety and effectiveness of chemoradiotherapy combined with immunotherapy as a postoperative adjuvant therapy for patients identified to be at risk of early cervical cancer based on MRD screening.

Publications & conference data

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

1. Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing.
   Kobayashi S, Nakamura Y, Hashimoto T, Bando H, et al · · 2025 · cited 6× · PMID 39920551 · DOI 10.1007/s10147-024-02683-0
2. The promise of PD1/PDL1 targeted immunotherapy in locally advanced cervical cancer: a game-changer for patients outcome?
   Kouhen F, El Ghanmi A, Inghaoun H, Miftah H, et al · · 2025 · cited 3× · PMID 40433369 · DOI 10.3389/fimmu.2025.1573576
3. Unraveling the prognostic puzzle: an in-depth exploration of lymph node metrics in surgically treated FIGO stage IB-IIA cervical cancer - A retrospective cohort study focused on the number of positive lymph nodes and the lymph node ratio.
   Song T, Chen X, Chen F, Wan Q, et al · · 2025 · PMID 40717572 · DOI 10.1097/js9.0000000000003033