A Single-arm, Prospective Clinical Study of Camrelizumab Combined With Apatinib Mesylate in the Treatment of Relapsed Platinum-resistant Epithelial Ovarian Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Camrelizumab
- Conditions
- Immune Checkpoint Inhibition
- Sponsor
- Qianfoshan Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Objective response rate
- Last Updated
- 5 years ago
Overview
Brief Summary
The aim of this study is to explore the effectiveness and safety of camrelizumab combined with apatinib mesylate in the treatment of relapsed platinum-resistant epithelial ovarian cancer
Detailed Description
The anti-PD-1 drug camrelizumab combined with apatinib mesylate was used to treat relapsed platinum-resistant epithelial ovarian cancer, and the effectiveness and safety of the treatment plan was evaluated by objective remission rate, progression-free survival, and major safety indicators , so as to provide patients a more beneficial treatment plan.
Investigators
Jing Liang
Professor
Qianfoshan Hospital
Eligibility Criteria
Inclusion Criteria
- •Age: 18 to 80 years old;
- •Histologically diagnosed as epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer;
- •Have received at least two lines of systemic chemotherapy;
- •Platinum resistance (disease progression occurs within 6 months after the last platinum-containing chemotherapy Development) or platinum refractory (disease progression during platinum-containing chemotherapy), ovarian cancer,Fallopian tube cancer, primary peritoneal cancer;
- •There are measurable lesions (according to RECIST 1.1 standard tumor lesion CT scan long diameter≥10mm, CT scan of lymph node lesions (short diameter≥ 10mm);
- •ECOG score: 0-1 points;
- •Estimated survival period ≥ 3 months;
- •The main organs function well, and the inspection indicators meet the following requirements:Routine blood examination: hemoglobin ≥90 g/L (no blood transfusion within 14 days); neutrophil count ≥1.5×109/L; platelet count ≥80×109/L; biochemical examination: total bilirubin ≤1.5×ULN ( Upper limit of normal); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT or AST ≤ 5×ULN; endogenous creatinine clearance ≥ 50 ml/min (Cockcroft -Gault formula);
- •The main organs are functioning normally, no blood transfusion or blood products within 14 days;
- •Subjects of childbearing age must agree to take effective contraceptive measures during the trial;Age women's serum or urine pregnancy test must be negative; non-lactating patients;
Exclusion Criteria
- •The subject has any active autoimmune disease or a history of autoimmune disease;
- •Severe allergic reaction to other monoclonal antibodies;
- •Suffer from other malignant tumors at the same time, except for malignant tumors that have been cured or have stable disease;
- •The subject has previously received anti-PD-1, anti-PD-L1, anti-CD137 or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies (including ipilimumab or any other specific targeting T cell Co-stimulation or checkpoint pathway antibodies or drugs) treatment;
- •Pregnant or breastfeeding women;
- •Patients who have used anti-angiogenesis therapy in the past, including bevacizumab, apatinib, or anlotinib;
- •Participated in other drug clinical trials within three months;
- •There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, ulcerative colitis and intestinal obstruction, etc.);
- •Any bleeding event with a severity level of CTCAE4.0 or higher in the 4 weeks before screening;
- •Patients with known central nervous system metastasis or a history of central nervous system metastasis before screening;
Arms & Interventions
camrelizumab+apatinib mesylate
Carmelizumab: Intravenous infusion of a fixed dose of 200 mg in 30 minutes (not less than 20 minutes, not more than 60 minutes), once every 3 weeks, continuous administration until the disease progresses, the patient If death or intolerable toxicity occurs, medication for up to 1 year; Apatinib mesylate tablets: The initial dose is 250 mg, administered once a day, and continue to be administered. If there is a grade 3 to 4 adverse reaction, it should be administered once every other day.
Intervention: Camrelizumab
Outcomes
Primary Outcomes
Objective response rate
Time Frame: within 1 year
the proportion of patients with tumor size reduction of a predefined amount
Secondary Outcomes
- Progression Free Survival(within 1 year)
- 6 months and 12 months overall survival(within 2 year)
- Disease Control Rate(within 1 year)
- drug safety(within 1 year)