Status:
ACTIVE_NOT_RECRUITING
Pd-1 Antibody Combined Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
Lead Sponsor:
Huazhong University of Science and Technology
Collaborating Sponsors:
Women's Hospital School Of Medicine Zhejiang University
Qilu Hospital of Shandong University
Conditions:
Uterine Cervical Neoplasm
Uterine Cervical Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Cervical cancer is one of the major health problems for chinese women. Besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies. However, n...
Detailed Description
Subjects will receive therapy Q3W until evaluation of efficacy. The first cycle include cisplatin and albumin-bound paclitaxel. A combination of anti-PD-1 antibody (SHR-1210) with cisplatin and albumi...
Eligibility Criteria
Inclusion
- Patients with locally advanced (2018 FIGO staged IB3, IIA2 and IIB/IIIC1r（tumor size ≥ 4cm) ) cervical cancer and had not received any treatment before.
- Histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix.
- Pathological examination of the PD-L1 positive（Combined score Positive Score≥1）.
- Females 18-70 years of age.
- Eastern Cooperative Oncology Group score 0-1.
- 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.
- Well-compliance and willing to keep in touch.
- Willing to participate in this study, and sign the informed consent.
Exclusion
- 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.
- HIV infection, active HBV/HCV.
- Condition requiring systemic treatment with small doses of corticosteroids within 1 months or large doses of corticosteroids within 3 months prior to randomization.
- Any primary malignancy within 5 years.
- Participate in other drug clinical trials at the same time.
- Pregnant or lactating female patients.
- 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.
- Drug or alcohol abuse.
- Unable or unwilling to sign informed consents.
- Not eligible for the study judged by researchers.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2028
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT04516616
Start Date
December 1 2020
End Date
July 1 2028
Last Update
March 20 2025
Active Locations (1)
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1
Tongji Hospital
Wuhan, Hubei, China, 430000