Cervical Cancer, Uterine Cervical Cancer, Uterine Cervical Neoplasm
Conditions
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, not all patients respond well to neoadjuvant chemotherapy. This is an open-label, single-arm, multi-center clinical trial to evaluate whether PD-1 in combination with neoadjuvant chemotherapy will achieve better objective response rate.
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 albumin-bound paclitaxel would be given in second and third cycles. Patients who have demonstrated complete or partial tumour responses （CR/PR）will receive surgery and receive postoperative adjuvant therapy in accordance with NCCN guideline. Patients who have demonstrated stable disease or progressive disease （SD/PD）will receive concurrent radiochemotherapy.
Interventions
DRUGCisplatin+Albumin-bound paclitaxel (1 cycle) and PD-1 monoclonal antibody+Cisplatin+Albumin-bound paclitaxel (2 cycles)
PD-1 monoclonal antibody （SHR-1210)：200mg，IV infusion，Q3W Cisplatin：75-80 mg/m2, IV infusion, Q3W Albumin-bound paclitaxel: 260 mg/m2，30min，IV infusion, Q3W
Sponsors
Women's Hospital School Of Medicine Zhejiang University
Qilu Hospital of Shandong University
Obstetrics & Gynecology Hospital of Fudan University
First Affiliated Hospital of Chongqing Medical University
Army Medical University, China
Peking University People's Hospital
Tianjin Medical University General Hospital
The Second Affiliated Hospital of Harbin Medical University
Chongqing University Cancer Hospital
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with locally advanced (2018 FIGO staged IB3, IIA2 and IIB/IIIC1r（tumor size ≥ 4cm) ) cervical cancer and had not received any treatment before. 2. Histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix. 3. Pathological examination of the PD-L1 positive（Combined score Positive Score≥1）. 4. Females 18-70 years of age. 5. Eastern Cooperative Oncology Group score 0-1. 6. 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. 7. Well-compliance and willing to keep in touch. 8. Willing to participate in this study, and sign the informed consent.
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. Drug or alcohol abuse. 9. Unable or unwilling to sign informed consents. 10. Not eligible for the study judged by researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 3 months | ORR is defined as the percentage of the participants in the ITT population who have a Complete Response or Partial Response. The ORR will be assessed by a blind independent central reviewer per RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological response rate | 3 months | Pathological response rate is defined as the percentage of the participants in the ITT population who have complete pathologic remission or the infiltration depth of cervical lesions was \< 3mm in histological examination. |
| Event-free survival (EFS) | 5 years | EFS defined as the time interval from the date of participation to disease progression, local or distant recurrence (in patients undergoing surgery), or death due to any cause. |
| Overall survival （OS） | 5 years | OS is defined as the time from the date of participation until death. |
Countries
China
Outcome results
None listed