cervical cancer
Conditions
Interventions
Treatment group:Pembrolizumab PLUS chemotherapy (paclitaxel PLUS cisplatin)
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Females 18-70 years of age. 2. Patients with locally advanced (2019 FIGO staged IB3, IIA2 and IIB/IIIC1r(tumor size> 4cm) ) cervical cancer and had not received any treatment before. Patients with persistent, recurrent, or metastatic cervical cancer. 3. Histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix. 4. The patient has not received systemic chemotherapy and cannot undergo curative treatment such as surgery and/or radiation therapy. 5. Not pregnant or breastfeeding, and at least one of the following conditions is met: a. Non-childbearing age women, b. Patients of childbearing age must agree to take effective contraception during treatment and for at least 120 days after the last dose of pembrolizumab, or for at least 210 days after the last dose of chemotherapy. 6. According to RECIST 1.1 standard, the patient has at least one target lesion with measurable diameter line. 7. Patients need to provide archival tumor tissue samples or newly obtained unirradiated tumor lesion specimens prior to enrollment to prospectively determine the patient's TLS status. 8. Eastern Cooperative Oncology Group score 0-1. 9. WBC=3.5*10^9/L, NEU=1.5*10^9/L, Platelet=80×10^9 /L; AST and ALT =1.5 times normal upper limit; Total bilirubin =1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen =the upper limit of normal value. 10. Well-compliance and willing to keep in touch. 11. Willing to participate in this study, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Active or known or suspected autoimmune disease requires a system treatment as follows but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring intervention with bronchodilators. 2. HIV infection, active HBV/HCV. 3. Condition requiring systemic treatment with small doses of corticosteroids within 1 months or large doses of corticosteroids within 3 months prior to randomization. 4. Any primary malignancy within 5 years. 5. Participate in other drug clinical trials at the same time. 6. Pregnant or lactating female patients. 7. Comorbidity including but not limited to: heart diseases (grade III-IV cardiac insufficiency (NYHA standard); central nervous system diseases or nonfunctional behavior; hematological system diseases; liver or kidney malformation or history of surgery. 8. Previously received treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or other immune checkpoint inhibitor drugs (such as CTLA4, OX40, CD137, etc.). 9. Previously received systemic chemotherapy treatment for cervical cancer. 10. Drug or alcohol abuse. 11. Unable or unwilling to sign informed consents. 12. Not eligible for the study judged by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic response rate;EFS;Tertiary lymphoid structure characteristics; | — |
Countries
China
Contacts
Public ContactFang Li
Shanghai East Hospital
Outcome results
None listed