Camrelizumab Combined With Apatinib in the Treatment of Epithelial Ovarian Cancer

A Single-arm, Prospective Clinical Study of Camrelizumab Combined With Apatinib Mesylate in the Treatment of Relapsed Platinum-resistant Epithelial Ovarian Cancer

NCT04507750•Qianfoshan Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1\. Age: 18 to 80 years old;
•2\. Histologically diagnosed as epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer;
•3\. Have received at least two lines of systemic chemotherapy;
•4\. 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;
•5\. 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);
•6\. ECOG score: 0-1 points;
•7\. Estimated survival period ≥ 3 months;
•8\. 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);
•9\. The main organs are functioning normally, no blood transfusion or blood products within 14 days;
•10\. 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;
+1 more criteria

Exclusion Criteria

•1\. The subject has any active autoimmune disease or a history of autoimmune disease;
•2\. Severe allergic reaction to other monoclonal antibodies;
•3\. Suffer from other malignant tumors at the same time, except for malignant tumors that have been cured or have stable disease;
•4\. 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;
•5\. Pregnant or breastfeeding women;
•6\. Patients who have used anti-angiogenesis therapy in the past, including bevacizumab, apatinib, or anlotinib;
•7\. Participated in other drug clinical trials within three months;
•8\. There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, ulcerative colitis and intestinal obstruction, etc.);
•9\. Any bleeding event with a severity level of CTCAE4.0 or higher in the 4 weeks before screening;
•10\. Patients with known central nervous system metastasis or a history of central nervous system metastasis before screening;
+10 more criteria

Locations (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

Key Dates

Start Date

August 10, 2020

Primary Completion Date

August 30, 2021

Completion Date

August 30, 2022

Last Updated

September 21, 2020

Enrollment

ESTIMATED participants

Conditions

Immune Checkpoint Inhibition

Interventions

Camrelizumab

DRUG

Contacts

Jing Liang, doctor

CONTACT

+8618663761275 liangjing0531@163.com