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Not yet recruiting NCT07649174

Cadonilimab Plus Chemotherapy in LACC: A Prospective, Multicenter, Randomized Phase II Trial

Phase II Interventional Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neoadjuvant Therapy Plus Surgery, Concurrent Chemoradiotherapy.
Who it may be relevant to
Registry conditions: Cervical Cancer. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy of Cadonilimab in Combination With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized Phase II Trial

Overview

This is a prospective, multi-center, randomized controlled phase II clinical trial aimed at exploring the efficacy evaluation of cadilonilumab immunotherapy combined with chemotherapy for locally advanced cervical cancer.

Interventions

  • Procedure Neoadjuvant Therapy Plus Surgery
    Patients received three cycles of neoadjuvant cadonilimab plus chemotherapy. Patients subsequently underwent radical hysterectomy with pelvic lymphadenectomy, with para-aortic lymph node biopsy/dissection performed when indicated. Postoperative adjuvant therapy was administered according to pathological findings.
  • Procedure Concurrent Chemoradiotherapy
    Patients received standard concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy combined with concurrent platinum-based chemotherapy.

Primary outcome measures

  • 2-year progression-free survival (PFS) rate [Time frame: 2 years after randomization]

Eligibility criteria

Inclusion criteria

  • Patients with previously untreated locally advanced cervical cancer, clinically staged as FIGO 2018 stage IB3, IIA2, IIB, or IIIC1r (tumor diameter >4 cm as assessed by contrast-enhanced pelvic MRI);
  • Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
  • Female patients aged ≥18 and ≤75 years;
  • Willing and able to provide written informed consent and comply with study visits and protocol-required procedures;
  • Eligible for radical hysterectomy with curative intent;
  • At least one measurable lesion according to RECIST version 1.1;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • Estimated life expectancy of at least 6 months;
  • Women of childbearing potential must agree to use effective contraception throughout the study period. A negative serum or urine pregnancy test is required before study enrollment.

Exclusion criteria

  • Histological subtypes other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, including but not limited to small cell carcinoma and clear cell carcinoma.
  • Clinically significant unrecoverable hydronephrosis;
  • CNS metastases or leptomeningeal disease;
  • Active malignancy within 3 years prior to enrollment (with specified exceptions);
  • Prior exposure to immune checkpoint inhibitors or other immunomodulatory anticancer therapies;
  • Major surgery within 4 weeks before study treatment;
  • Severe cardiovascular or cerebrovascular disease;
  • Unresolved toxicities from previous anticancer therapy (> Grade 1, CTCAE v5.0);
  • Known hypersensitivity to study drugs;
  • Serious medical or psychiatric conditions that may interfere with study participation;
  • Pregnancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Obstetrics and Gynecology Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT07649174 · FUOBGY-2026-55 · 2025ZD0544104 · 2025YFC3508302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗