Study of Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical squamous cell carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhujiang Hospital
• Treatments: Cisplatin; Nimotuzumab

Criteria

Inclusion Criteria:

• All volunteers will sign the informed consent.

• Histologically confirmed squamous cell of the uterine cervix, EGFR(+).

• The FIGO stage (IIB-IVA) and was not available for surgical treatment.

• There is at least one tumor lesion that is measurable by RECIST.

• During the study, contraception should be ensured.

• Karnofsky performance status >60.

• WBC >= 3,000/mm^3

• Absolute granulocyte count >= 1,500/mm^3

• Platelet count >= 100,000/mm^3

• INR < 1.5

• Total bilirubin =< 1.5 mg/dL

• Serum creatinine =< 1.5 mg/dL

• AST and ALT =< 2.5 times upper limit of normal (ULN)

• Serum calcium =< 1.3 times ULN

• Hemoglobin >= 9g/dL (transfusion allowed)

Exclusion Criteria:

• Positive para-aortic lymph nodes or positive lymph nodes beyond pelvic

• Prior invasive malignancy (except nonmelanomatous skin cancer)

• Contraindication of chemotherapy;

• Rare pathological subtype;

• Cervical cancer patients underwent hysterectomy, laparoscopic surgery or systemic chemotherapy.