Ovarian cancer
Conditions
Interventions
Test group:fecal microbiota transplantation capsules and PD-1 antibody
Sponsors
Shanghai Tenth People's Hospital,Tongji University
Eligibility
Sex/Gender
Female
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: To be enrolled, participants must meet all of the following inclusion criteria: 1) 45 years = age = 70 years; 2) Karnofsky = 60 or ECOG score 0-2; 3) Patients with advanced ovarian cancer: FIGO stage III-IV patients; 4) Patients with refractory ovarian cancer: including platinum-sensitive relapse, platinum-resistant relapse (progression within 6 months after platinum-based chemotherapy), or disease progression during subsequent treatment in patients with relapse of previous disease; 5) Patients with measurable lesions available for diagnostic imaging and suitable for assessment of tumor response and progression according to RECIST 1.1 criteria; 6) Life expectancy > 3 months; 7) Sufficient understanding and voluntary signing of informed consent; 8) Ability to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1) previous treatment with immune checkpoint inhibitors; 2) previous systemic corticosteroid therapy; 3) concurrent other types of malignancies, infectious diseases, acute progressive diseases, CNS metastatic diseases, immune-related diseases (inflammatory bowel disease, autoimmune diseases, immunocompromised states, etc.); 4) patients with contraindications to the use of FMT; 5) history of radiotherapy within 1 month, or being treated with other therapeutic agents: e.g., biologic drugs, proprietary Chinese medicines; 6) adverse reactions to previous antitumor therapy have not recovered to a CTCAE version 4.0 grade rating =1; 7) the subject has a history of other serious systemic diseases or is otherwise unsuitable for participation in this clinical study, in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Countries
China
Contacts
Public ContactGuihai Ai
Shanghai Tenth People's Hospital, Tongji University
Outcome results
None listed