Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC

Summary

It is a prospective, open-label, randomized, controlled phase II/III clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors \>4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group.

Conditions

• Cervical Cancer
• Locally Advanced Cervical Cancer
• Concurrent Chemoradiotherapy
• Neoadjuvant Chemoimmunotherapy

Interventions

DRUG

Camrelizumab

Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery

DRUG

Cisplatin

Cisplatin：75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min.

DRUG

Nab paclitaxel

Nab paclitaxel: 260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.

PROCEDURE

Radical surgery

Radical surgery

RADIATION

external beam radiation therapy (EBRT) + brachytherapy

Radiation therapy per standard of care

DRUG

Cisplatin

Chemotherapy administered concurrent with radiation therapy，cisplatin 40 mg/m2 IV once per week (QW) for 5 weeks

Sponsors & Collaborators

• Southwest Hospital, China

  collaborator OTHER

• Women's Hospital School Of Medicine Zhejiang University

  collaborator OTHER

• Anhui Provincial Cancer Hospital

  collaborator OTHER

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Beijing Friendship Hospital

  collaborator OTHER

• Tianjin Medical University General Hospital

  collaborator OTHER

• West China Second University Hospital

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Gansu Provincial Maternal and Child Health Care Hospital

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Cancer Hospital of Guangxi Medical University

  collaborator OTHER

• Tongji Hospital

  lead OTHER

Principal Investigators

• Ding Ma · Tongji Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-22

Primary Completion

2031-03-01

Completion

2031-03-01

Countries

• China

Study Locations