Cervical Cancer
Conditions
Keywords
cervical cancer, Immunotherapy, Neoadjuvant therapy
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.
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.
Sponsors
Obstetrics & Gynecology Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year progression-free survival (PFS) rate | 2 years after randomization | 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. |
Countries
China
Contacts
CONTACTXin Wu
Outcome results
None listed