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Not yet recruitingNCT07649174Updated Jun 16, 2026

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

A Phase 2 interventional study of Neoadjuvant Therapy Plus Surgery and Concurrent Chemoradiotherapy in Cervical Cancer, sponsored by Obstetrics & Gynecology Hospital of Fudan University. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Obstetrics & Gynecology Hospital of Fudan University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Cervical Cancer

Keywords

  • cervical cancer
  • Immunotherapy
  • Neoadjuvant therapy
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. 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);
  2. Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
  3. Female patients aged ≥18 and ≤75 years;
  4. Willing and able to provide written informed consent and comply with study visits and protocol-required procedures;
  5. Eligible for radical hysterectomy with curative intent;
  6. At least one measurable lesion according to RECIST version 1.1;
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  8. Estimated life expectancy of at least 6 months;
  9. 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

Exclusion Criteria:

  1. Histological subtypes other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, including but not limited to small cell carcinoma and clear cell carcinoma.
  2. Clinically significant unrecoverable hydronephrosis;
  3. CNS metastases or leptomeningeal disease;
  4. Active malignancy within 3 years prior to enrollment (with specified exceptions);
  5. Prior exposure to immune checkpoint inhibitors or other immunomodulatory anticancer therapies;
  6. Major surgery within 4 weeks before study treatment;
  7. Severe cardiovascular or cerebrovascular disease;
  8. Unresolved toxicities from previous anticancer therapy (> Grade 1, CTCAE v5.0);
  9. Known hypersensitivity to study drugs;
  10. Serious medical or psychiatric conditions that may interfere with study participation;
  11. Pregnancy.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
134 participants (estimated)

Study arms

  • Experimental
    Experimental arm

    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

  • Active comparator
    Control arm

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

    Procedure: Concurrent Chemoradiotherapy

Interventions

  • ProcedureNeoadjuvant 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.

  • ProcedureConcurrent Chemoradiotherapy

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

05

What researchers measure

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.

    Time frame: 2 years after randomization

06

Study locations

1 site
  • Obstetrics and Gynecology Hospital of Fudan University
    Shanghai, 201101, China
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07649174
Lead sponsor
Obstetrics & Gynecology Hospital of Fudan University
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
Jun 6, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Jun 16, 2026

Study contacts

Xin Wu
Contact
wuxin_fc@fudan.edu.cn
86 21 33189900

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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