Back to resultsPd-1 Antibody Combined Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
Primary Purpose
Uterine Cervical Neoplasm, Uterine Cervical Cancer, Cervical Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cisplatin+Albumin-bound paclitaxel (1 cycle) and PD-1 monoclonal antibody+Cisplatin+Albumin-bound paclitaxel (2 cycles)
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Cervical Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Patients with locally advanced (2019 FIGO staged IB3, IIA2 and IIB（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 18-65 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 Criteria:
- 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.
Sites / Locations
- Tongji HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
Patients receive 1 cycle of cisplatin and albumin-bound paclitaxel combined neoadjuvant chemotherapy and subsequent 2 cycles of PD-1 antibody combined neoadjuvant chemotherapy.
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
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 Outcome Measures
Pathological response rate
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)
EFS defined as the time interval from the date of randomization to disease progression, local or distant recurrence (in patients undergoing surgery), or death due to any cause.
Overall survival （OS）
OS is defined as the time from the date of randomization until death.
Full Information
NCT ID
NCT04516616
First Posted
August 13, 2020
Last Updated
March 7, 2023
Sponsor
Huazhong University of Science and Technology
Collaborators
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, Peking University People's Hospital, Tianjin Medical University General Hospital, Harbin Medical University, Chongqing University Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04516616
Brief Title
Pd-1 Antibody Combined Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
Official Title
Study of Pd-1 Antibody in Combination With Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
July 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
Collaborators
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, Peking University People's Hospital, Tianjin Medical University General Hospital, Harbin Medical University, Chongqing University Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasm, Uterine Cervical Cancer, Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients receive 1 cycle of cisplatin and albumin-bound paclitaxel combined neoadjuvant chemotherapy and subsequent 2 cycles of PD-1 antibody combined neoadjuvant chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Cisplatin+Albumin-bound paclitaxel (1 cycle) and PD-1 monoclonal antibody+Cisplatin+Albumin-bound paclitaxel (2 cycles)
Intervention Description
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
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pathological response rate
Description
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.
Time Frame
3 months
Title
Event-free survival (EFS)
Description
EFS defined as the time interval from the date of randomization to disease progression, local or distant recurrence (in patients undergoing surgery), or death due to any cause.
Time Frame
5 years
Title
Overall survival （OS）
Description
OS is defined as the time from the date of randomization until death.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with locally advanced (2019 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 18-65 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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ding Ma, M.D., PhD
Phone
0086-27-836268
Email
dma@tjh.tjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ding Ma, M.D., PhD
Organizational Affiliation
Tongji Hospital, Tongji Medical College, HUST
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ding Ma, M.D., PhD
Phone
0086-27-8362681
Email
dma@tjh.tjmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
5 years after completion of the study
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Learn more about this trial
Pd-1 Antibody Combined Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
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