Phase II Clinical Trial of Concurrent Chemoradiotherapy Combined Nimotuzumab for Stage IIB-IVA Cervical Cancer

• Status: Unknown status
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

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

Details

• Lead Sponsor: Air Force Military Medical University, China; Fourth Military Medical University
• Treatments: Cisplatin; Nimotuzumab

Criteria

Inclusion Criteria:

• 18 Years to 70 Years，female

• Histological diagnosis of squamous cell carcinoma of cervix, FIGO stage IIB-IVA,with diameter 4-6 cm, without distant metastasis.

• no chance of surgery confirmed by more than two deputy chief doctors of gynecology.

• Moderate or high expression of EGFR

• The function of main organ is normal, including blood, heart, lung, liver, and kidney. Without history of hypertension, stroke. Blood pressure is normal before treatment.

• WBC≥3.5×10E9/L，ANC≥1.5×10E9/L；HB≥90g/L，PLT≥100×10E9/L

• ALT, AST and Cr below 1.5 times of normal level

• Willing to accept treatment

• Ability to comply with trial requirements KPS≥70

Exclusion Criteria:

• Evidence of distance metastasis

• Impossible to measure the diameter of tumor, or the tumor is too huge (diameter>6cm)

• Couldn't examine with pelvic MRI due to a variety of reasons

• Used to treat with radiotherapy chemotherapy or molecular target therapy and immune therapy

• Diagnosed with another malignant tumor in 5 years

• Used to be a volunteer of other clinical trial.

• Used to be allergic reaction with grade 3 or 4 degree to any experimental drugs

• Severe medical history of lung ,liver, kidney or heart.

• Active infection in any part of the whole body.

• Examination results showed radiotherapy contraindications