Phase
Condition
Cervical Cancer
Vaginal Cancer
Chemotherapy
Treatment
Toripalimab
Clinical Study ID
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Untreated locally advanced cervical cancer patients with clear pathologicaldiagnosis
2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameterof their metastatic lymph nodes should ≥1.5cm
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Life expectancy > 6 months
Able to tolerate concurrent chemoradiotherapy assessed by researches
No obvious active bleeding;
Adequate hematological, renal and hepatic functions:
No concomitant malignancies
Female subjects of childbearing potential should have a negative pregnancy test andmust take effective and reliable contraceptive measures during the clinical trialperiod;
Voluntarily-signed informed consent.
Exclusion
Exclusion Criteria:
Concomitant other malignancies;
Patients with metastatic or recurrent disease;
Patients received any form of treatment before enrollment;
Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acuteinfections;
Impaired hematological, renal or hepatic functions:
Hemoglobin < 9.0 g/dl
Neutrophils < 2000 cells/μl; Leukocytes < 4 × 109/L
Platelets > 100 × 109/L
Serum ALT/AST > 2.5×UNL
Serum Total bilirubin > 1.5× UNL g. Serum urea nitrogen (BUN) > 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) > 1.5 × upper normal limit (UNL)
Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricularblock, cardiac insufficiency or severe heart valve disease;
Patients with uncontrolled mental diseases;
Pregnant or lactating woman;
Participating in other clinical trials;
Anyone considered not suitable for enrollment by principal investigator;
Study Design
Study Description
Connect with a study center
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin 300060
ChinaActive - Recruiting
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