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

NCT07649174 | Not Yet Recruiting Phase 2 DMC

• 3 other identifiers: FUOBGY-2026-552025ZD05441042025YFC3508302
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer

Keywords

cervical cancer; Immunotherapy; Neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• 2-year progression-free survival (PFS) rate

  The proportion of patients who remain alive without radiologically confirmed disease progression at 2 years after randomization. Disease progression will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on imaging evaluations.

  2 years after randomization

Study Arms (2)

Experimental arm

EXPERIMENTAL

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: Neoadjuvant Therapy Plus Surgery

Control arm

ACTIVE COMPARATOR

Patients received standard concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy combined with concurrent platinum-based chemotherapy.

Procedure: Concurrent Chemoradiotherapy

Interventions

Neoadjuvant Therapy Plus Surgery PROCEDURE

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.

Experimental arm

Concurrent Chemoradiotherapy PROCEDURE

Patients received standard concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy combined with concurrent platinum-based chemotherapy.

Control arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University: lead

Study Sites (1)

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, 201101, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Neoadjuvant Therapy; Surgical Procedures, Operative; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Xin Wu

CONTACT

86 21 33189900; wuxin_fc@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: June 6, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)