cervical cancer
Conditions
Interventions
Experimental group:Sintilimab in combination with bevacizumab
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. For patients with recurrent or metastatic cervical cancer after first-line or more platinum-containing standard therapy, first-line chemotherapy can include any of the following: (1) Platinum drugs + taxane drugs; (2) Platinum drugs + topotecan; at least one lesion meets the RECISTv1.1 target lesion criteria; 2. Previous histologically confirmed cervical adenocarcinoma, cervical squamous cell carcinoma or cervical adenosquamous carcinoma; 3. Surgical resection or radiotherapy is not recommended for recurrent lesions, or the patient voluntarily chooses not to undergo surgery or radiotherapy; 4. The investigator evaluates that it is suitable to receive this treatment; 5. ECOG 0-1; life expectancy > 3 months; 6. Aged 18-75 years; 7. No serious allergic history; 8. Hemoglobin>=90 g/L, WBC>=3.5x10^9/L, neutrophil ANC>=1.5x10^9/L, platelets>=100x109/L; Cr<=1.5xULN (Upper limit of normal) , TBIL<=1.5xULN; AST and ALT<=2.5xULN, international normalized ratio INR or plasma prothrombin time PT<=1.5xULN; 9. The patient participates voluntarily, is fully informed and able to sign the informed consent form; willing to follow and able to complete all trial procedures.
Exclusion criteria
Exclusion criteria: 1. There are primary malignant tumors with activity in other parts, except for the following cases: (1) Cured malignancies with no known active disease >= 5 years prior to the first IP administration, and a low potential risk of recurrence; (2) Adequate treatment of non-melanoma skin cancer or malignant mole, and no signs of disease; (3) Adequately treated carcinoma in situ with no evidence of disease; 2. Recurrent lesions have been treated with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, or anti-lymphocyte antigen 4 (CTLA-4) antibody; 3. Recurrent lesions have received anti-VEGF antibody therapy, etc.; 4. Pregnant or lactating patients; 5. There is abnormal thyroid function in the past, and in the case of drug treatment, the thyroid function still cannot be maintained within the normal range; 6. Patients who need to receive systemic corticosteroids (dose equivalent to or higher than 10 mg/d prednisone) or other immune drugs 14 days before enrollment or during the study; 7. Suffering from active autoimmune disease and requiring systemic treatment within the past 2 years; 8. Those who have received live vaccine within 4 weeks of starting treatment, or who have received anti-tumor vaccine; 9. Patients with known history of human immunodeficiency virus (HIV) infection or other acquired or congenital immunodeficiency; 10. Patients with known history of hepatitis B or known active hepatitis C virus infection and syphilis; 11. Known history of active tuberculosis (TB; Mycobacterium tuberculosis); 12. Uncontrolled comorbidities, including but not limited to: persistent or active infection, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled liver and kidney disease, uncontrolled diabetes, uncontrolled bleeding disorders, uncontrolled cardiovascular and cerebrovascular disorders, uncontrolled pulmonary disorders, uncontrolled gastrointestinal perforation/wound dehiscence syndrome, severe chronic gastrointestinal disorders with diarrhea, or a psychiatric/social condition that may limit compliance with study requirements, cause a significantly increased risk of AEs, or interfere with a subject's ability to provide written informed consent; 13. Major surgery or severe trauma has been performed 28 days before enrollment and has not recovered; 14. History of alcohol, drug or drug abuse in the past 1 year; history of clear neurological or mental disorders in the past; 15. Received other anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, traditional Chinese medicine, immunotherapy, etc.) within 4 weeks before the start of treatment, or participated in other clinical studies; 16. Allogeneic tissue/solid organ transplantation was performed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Duration of relief; | — |
Countries
China
Contacts
Public ContactZhang Meiqin, Huang Yan
Fudan University Shanghai Cancer Center
Outcome results
None listed