Ovarian Cancer
Conditions
Interventions
Experimental group:Carrilizumab 200mg+ bevacizumab 15mg/kg Q3W
Sponsors
The Obstetrics & Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Through multi line treatment: those who have received second-line or above chemotherapy regimens (neoadjuvant+adjuvant chemotherapy/adjuvant chemotherapy counted as one chemotherapy line), and whose last line of treatment before enrollment has failed (treatment failure is defined as intolerance to the toxic side effects of treatment, disease progression during treatment, or disease recurrence/progression (including clinical progression) after treatment); 2) At least one lesion meets the RECIST v1.1 target lesion criteria; 3) High grade serous adenocarcinoma of the ovary confirmed by previous histology; 4) Samples from first-time or recurrent surgeries can be obtained, which can be used to detect C5aR1 and PD-L1 levels. Patients with low C5aR1 expression and high PD-L1 expression can be selected according to the criteria; 5) Surgical resection or continued chemotherapy/targeted therapy is not recommended for recurrent lesions, or patients voluntarily choose not to undergo surgery or radiation therapy; 6) Researchers evaluate suitability for receiving this treatment; 7) ECOG 0-1 level; Expected lifespan>3 months; 8) Age range: 18-75 years old; 9) No history of severe allergies; 10) Hemoglobin >= 90 g/L, WBC >= 3.5 × 10^9/L, neutrophil ANC >= 1.5 × 10^9/L, platelets >= 100 × 10^9/L; Cr <=1.5 × ULN (normal upper limit), TBIL <= 1.5 × ULN; AST and ALT <= 2.5 × ULN, international standardized ratio INR or plasma prothrombin time PT <= 1.5 × ULN; 11) The patient voluntarily participates, fully understands and is able to sign an informed consent form; Willing to follow and capable of completing all experimental procedures.
Exclusion criteria
Exclusion criteria: 1) Histologically diagnosed as low-grade serous adenocarcinoma, clear cell carcinoma, mucinous adenocarcinoma, low-grade endometrioid carcinoma or carcinosarcoma, and other pathological types; 2) Primary malignant tumors with activity in other parts of the body, except for the following situations: a cured malignant tumor with no known active disease for >= 5 years before the first administration of IP, and a low potential risk of recurrence; Fully treat non melanoma skin cancer or malignant nevi without any signs of disease; Fully treated carcinoma in situ with no signs of disease; 3) The recurrent lesion has received treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, or anti-CTLA-4 antibody; 4) The recurrent lesion has received treatment with anti VEGF antibodies, etc; 5) Individuals who are allergic to any known test drug ingredients; 6) Pregnant or lactating patients; 7) Patients who need to receive systemic corticosteroids (doses equivalent to or higher than 10mg/d prednisone) or other immunotherapy drugs 14 days before enrollment or during the study period; 8) Suffering from active autoimmune diseases and requiring systemic treatment within the past 2 years; 9) Known history of human immunodeficiency virus (HIV) infection or other acquired or congenital immunodeficiency patients; 10) Patients with a known history of hepatitis B or known active hepatitis C virus infection and syphilis; 11) Have a known history of active tuberculosis (TB; tubercle bacillus); 12) Uncontrolled concomitant diseases, including but not limited to: persistent or active infection, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled liver and kidney diseases, uncontrolled diabetes, uncontrolled hemorrhagic diseases, uncontrolled cardiovascular and cerebrovascular diseases; 13) Received other anti-tumor treatments (including chemotherapy, radiotherapy, targeted therapy, traditional Chinese medicine, immunotherapy, etc.) within 4 weeks before the start of treatment, or participated in other clinical studies; 14) The researchers believe that they are not suitable to participate in the study due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of remission,DOR;Disease control rate,DCR;Overall survival,OS;progression-free survival,PFS;time to progress,TTP;Adverse events occurred during treatment,AEs; | — |
Countries
China
Contacts
Public ContactWei Jiang; Guodong Zhang
The Obstetrics & Gynecology Hospital of Fudan University
Outcome results
None listed