Status:
UNKNOWN
CCRT Combined With Endostar for the Treatment of Locally Advanced Cervical Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age from 18 to 65 years old;
- Histologically confirmed to be cervical squamous cell carcinoma;
- Clinical stage IIB (need to have lymph node metastasis), IIIA, IIIB, IVA (2018 version of FIGO stage);
- The ECOG PS score is 0 or 1;
- At least one measurable (measured according to RECIST 1.1);
- No distant organ metastasis confirmed by abdominal CT, chest CT, bone ECT, etc;
- This treatment must be the first course of treatment;
- The expected survival expectation is not less than 6 months;
- The main organ function meets the following criteria within 7 days before treatment:
- Blood routine examination standard (without blood transfusion within 14 days):
- hemoglobin (HB) ≥ 90g / L;
- neutrophil absolute value (ANC) ≥ 1.5 × 10 9 / L;
- platelets (PLT) ≥ 80 × 10 9 / L.
- Biochemical tests are subject to the following criteria:
- total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
- alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 times ULN;
- 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
- Patients with distant metastases;
- Those suffering from other malignant tumors;
- Have received cancer-related treatment such as radiotherapy or chemotherapy before enrollment;
- Patients with contraindications to radiotherapy and chemotherapy, including serious infections or other complications such as severe cerebrovascular disease, mental illness and uncontrollable diabetes;
- During pregnancy or lactation;
- Those who have received targeted therapy;
- Those who are in other drug trials;
- Those with serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension;
- It is known that there is a hypersensitivity reaction to any component contained in the Endostar formulation;
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04121975
Start Date
August 1 2019
End Date
August 1 2022
Last Update
October 10 2019
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China