ccrt combined with endostar for the treatment of locally advanced cervical cancer

Conditions: Cervical Cancer

Summary: this was a prospective, single arm, phase 2 trial. adult patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with endostar. the primary endpoint was progression-free survival (pfs) rate at 1 year. the secondary endpoints were pfs, overall survival (os) and safety.

this was a prospective, single arm, phase 2 trial. adult patients with histologically confirmed locally advanced cervical cancer were enrolled to receive the treatment of concurrent chemoradiotherapy combined with endostar. radiotherapy was administered in 1.8-2.0 gy fractions 5 times weekly to a total dose of 45-50 gy. endostar (30 mg/d) was administered on days 1-5 every two weeks for 4 cycles. cisplatin (30-40 mg/m2) was administered day 1, 8, 15, 22 and 29. the primary endpoint was progression-free survival (pfs) rate at 1 year. the secondary endpoints were pfs, overall survival (os) and safety.

Eligibility criteria:
inclusion criteria: 1. age from 18 to 65 years old; 2. histologically confirmed to be cervical squamous cell carcinoma; 3. clinical stage iib (need to have lymph node metastasis), iiia, iiib, iva (2018 version of figo stage); 4. the ecog ps score is 0 or 1; 5. at least one measurable (measured according to recist 1.1); 6. no distant organ metastasis confirmed by abdominal ct, chest ct, bone ect, etc; 7. this treatment must be the first course of treatment; 8. the expected survival expectation is not less than 6 months; 9. the main organ function meets the following criteria within 7 days before treatment: blood routine examination standard (without blood transfusion within 14 days): 1. hemoglobin (hb) ≥ 90g / l; 2. neutrophil absolute value (anc) ≥ 1.5 × 10 9 / l; 3. platelets (plt) ≥ 80 × 10 9 / l. biochemical tests are subject to the following criteria: 1. total bilirubin (tbil) ≤ 1.5 times the upper limit of normal (uln); 2. alanine aminotransferase (alt) and aspartate aminotransferase ast ≤ 2.5 times uln; 3. serum creatinine (cr) ≤ 1.5 times uln or creatinine clearance (ccr) ≥ 60ml / min; doppler ultrasound assessment: left ventricular ejection fraction (lvef) ≥ normal low limit (50%). (10) women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy tests within 7 days prior to study enrollment and must be non-lactating patients; (11) can understand the study and have signed an informed consent form; exclusion criteria: 1. patients with distant metastases; 2. those suffering from other malignant tumors; 3. have received cancer-related treatment such as radiotherapy or chemotherapy before enrollment; 4. patients with contraindications to radiotherapy and chemotherapy, including serious infections or other complications such as severe cerebrovascular disease, mental illness and uncontrollable diabetes; 5. during pregnancy or lactation; 6. those who have received targeted therapy; 7. those who are in other drug trials; 8. those with serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension; 9. it is known that there is a hypersensitivity reaction to any component contained in the endostar formulation;