Camrelizumab Combined With Apatinib in the Treatment of Epithelial Ovarian Cancer

NCT04507750 | Unknown

• 1 other identifier: XYLL-KY-2020-(028)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Immune Checkpoint Inhibition

Keywords

camrelizumab; apatinib

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  the proportion of patients with tumor size reduction of a predefined amount

  within 1 year

Secondary Outcomes (4)

• Progression Free Survival

  within 1 year

• Disease Control Rate

  within 1 year

• drug safety

  within 1 year

• 6 months and 12 months overall survival

  within 2 year

Study Arms (1)

camrelizumab+apatinib mesylate

EXPERIMENTAL

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.

Drug: Camrelizumab

Interventions

Camrelizumab DRUG

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.

Also known as: apatinib mesylate

camrelizumab+apatinib mesylate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;
• \. Subjects voluntarily join the study and sign an informed consent form, with good compliance and matchingClose follow-up.

You may not qualify if:

• \. 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;
• \. Patients with hypertension who cannot be well controlled by a single antihypertensive drug treatment (systolic blood pressure\> 140 mmHg, diastolic blood pressure\> 90 mmHg); people with a history of unstable angina; a new diagnosis of angina within 3 months before screening Patients or myocardial infarction events occurred within 6 months before screening; Arrhythmia (including QTcF) requires long-term use of antiarrhythmic drugs and New York Heart Association grade ≥ Grade II cardiac insufficiency;
• \. Long-term unhealed wounds or fractures with incomplete healing;
• \. Have a history of organ transplantation;
• \. Imaging shows that the tumor has invaded important blood vessels or the researcher has judged that the patient's tumor is highly likely to invade important blood vessels and cause fatal bleeding during treatment;
• \. Abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\<2g/L), those with bleeding tendency (14 days before randomization must meet: INR is normal without using anticoagulants Within the range of values); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; on the premise of prothrombin time international normalized ratio (INR) ≤ 1.5, use for preventive purposes is permitted Low-dose warfarin (1 mg orally, once a day) or low-dose aspirin (do not exceed 100 mg per day);

Sponsors & Collaborators

• Qianfoshan Hospital: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; apatinib

Study Officials

• Liang Jing, doctor

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Liang, doctor

CONTACT

+8618663761275; liangjing0531@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 11, 2020
• Study Start: August 10, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2022
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)