Pd-1 Antibody Combined Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer

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ClinicalTrials.gov Identifier: NCT04516616

Recruitment Status : Recruiting

First Posted : August 18, 2020

Last Update Posted : January 22, 2021

See Contacts and Locations

Sponsor:

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

Information provided by (Responsible Party):

Ding Ma, Huazhong University of Science and Technology

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.

Condition or disease	Intervention/treatment	Phase
Uterine Cervical Neoplasm Uterine Cervical Cancer Cervical Cancer	Drug: Cisplatin+Albumin-bound paclitaxel (1 cycle) and PD-1 monoclonal antibody+Cisplatin+Albumin-bound paclitaxel (2 cycles)	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	84 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Study of Pd-1 Antibody in Combination With Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
Actual Study Start Date :	December 1, 2020
Estimated Primary Completion Date :	December 1, 2021
Estimated Study Completion Date :	September 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Drug Information available for: Globulin, Immune Cisplatin Paclitaxel

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Study group Patients receive 1 cycle of cisplatin and albumin-bound paclitaxel combined neoadjuvant chemotherapy and subsequent 2 cycles of PD-1 antibody combined neoadjuvant chemotherapy.	Drug: Cisplatin+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

Outcome Measures

Primary Outcome Measures :

Objective Response Rate (ORR) [ Time Frame: 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 Outcome Measures :

Pathological response rate [ Time Frame: 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.
Disease-free survival (DFS) [ Time Frame: 5 years ]
DFS is defined as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.
Overall survival （OS） [ Time Frame: 5 years ]
OS is defined as the time from the date of randomization until death.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04516616

Contacts

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Contact: Ding Ma, M.D., PhD	0086-27-836268	dma@tjh.tjmu.edu.cn

Locations

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China, Hubei
Tongji Hospital	Recruiting
Wuhan, Hubei, China, 430000
Contact: Ding Ma, M.D., PhD 0086-27-8362681 dma@tjh.tjmu.edu.cn

Sponsors and Collaborators

Huazhong University of Science and Technology