Cadonilimab Plus Chemotherapy in LACC: A Prospective, Multicenter, Randomized Phase II Trial
Starting soon · Phase 2
Conditions studied: Cervical Cancer
In brief
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.
Key facts
- Study ID
- NCT07649174
- Run by
- Obstetrics & Gynecology Hospital of Fudan University
- People needed
- 134
- Starts
- 2026-06-06
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2026-06-16
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Obstetrics and Gynecology Hospital of Fudan University — Shanghai, China
Full record on ClinicalTrials.gov
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