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

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.

Conditions

• Uterine Cervical Neoplasm
• Uterine Cervical Cancer
• Cervical Cancer

Interventions

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

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Obstetrics & Gynecology Hospital of Fudan University

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Army Medical University, China

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Tianjin Medical University General Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Chongqing University Cancer Hospital

  collaborator OTHER

• The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)

  collaborator OTHER

• Huazhong University of Science and Technology

  lead OTHER

Principal Investigators

• Ding Ma, M.D., PhD · Tongji Hospital, Tongji Medical College, HUST

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-01

Primary Completion

2023-04-30

Completion

2028-07-01

Countries

• China

Study Locations