Clinical trial · Interventional
Cadonilimab Plus Chemotherapy in LACC: A Prospective, Multicenter, Randomized Phase II Trial
Efficacy of Cadonilimab in Combination With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized Phase II Trial
NCT07649174CI-TRIAL-00114885not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent Chemoradiotherapy | Procedure | — | UNRESOLVED |
| Neoadjuvant Therapy Plus Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- 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.
- interventionNames
- Procedure: Neoadjuvant Therapy Plus Surgery
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- Patients received standard concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy combined with concurrent platinum-based chemotherapy.
- interventionNames
- Procedure: Concurrent Chemoradiotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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: 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.
References
Publications (0)
Data not yet available
No reference posted for this study.