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

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

Study Overview

• Status: Unknown
• Conditions: Immune Checkpoint Inhibition
• Intervention / Treatment: Drug: Camrelizumab

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing Liang, doctor; Phone Number: +8618663761275; Email: liangjing0531@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • Shandong Provincial Qianfoshan Hospital
      • Contact: Jing Liang, doctor; Phone Number: +8618663761275; Email: liangjing0531@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

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

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;

  11. 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;

  12. Long-term unhealed wounds or fractures with incomplete healing;

  13. Have a history of organ transplantation;

  14. 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;

  15. 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);

  16. Arterial/venous thrombosis events occurred in the year before screening, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (venous thrombosis caused by intravenous catheterization due to pre-chemotherapy, except those who have been cured by the investigator ) And pulmonary embolism;

  17. People with a history of psychotropic drug abuse and unable to quit or have mental disorders;

  18. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.

  19. Live vaccines may be vaccinated during the study period less than 4 weeks before the study medication;

  20. Other researchers believe that it is not suitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: Camrelizumab; 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.; Other Names: apatinib mesylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	the proportion of patients with tumor size reduction of a predefined amount	within 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse	within 1 year
Disease Control Rate	Refers to the percentage of confirmed complete remission, partial remission and stable disease (≥ 8 weeks) among patients with evaluable efficacy.	within 1 year
drug safety	Incidence of test drug relative adverse events,Incidence of serious adverse events	within 1 year
6 months and 12 months overall survival	It is the percentage of people in a study or treatment group still alive for a given period of time after diagnosis	within 2 year

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Liang Jing, doctor, Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Anticipated): August 30, 2021
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: apatinib; camrelizumab
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: XYLL-KY-2020-(028)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No