NCT05556200

A Phase II Trial of Camrelizumab in Combination With Apatinib for Neoadjuvant Treatment of Early-stage TNBC With a High Proportion of TILs

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, open-labeled, multi-centered, single-arm, investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with apatinib (a VEGFR2 TKI) for neoadjuvant treatment of patients with triple-negative breast cancer and \>10% tumor-infiltrating lymphocytes (TILs) in baseline breast tumors. We will enroll 58 subjects (Simon's two stage design). The study is designed to evaluate the efficacy and safety of camrelizumab in combination with apatinib in the neoadjuvant treatment of TNBC with a high proportion of TILs.

Detailed description

This a phase II, open-labeled, multi-centered, single-arm, investigator-initiated clinical trial to assess the efficacy and safety of camrelizumab combination with apatinib in female patients age of 18 to 70 with TNBC, and baseline tumor-infiltrating lymphocytes \> 10%. The number of patients to be included is 58 patients (Simon's two stage design). The primary objective is to assess the pCR. All enrolled patients will be treated with camrelizumab 200mg (iv. 3mg/kg for patient whose weight is below 50kg) on day 1 of each 21-day cycle, and apatinib 250mg daily (po, d1-d21).

Conditions

• Breast Cancer
• Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Anti-PD-1 monoclonal antibody	Camrelizumab 200 mg, iv, d1, q3W (3 mg/kg if weight \<50 kg)
DRUG	VEGFR2 Tyrosine Kinase Inhibitor	Apatinib 250 mg, po, qd

Timeline

• Start date: 2022-12-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2022-09-27
• Last updated: 2023-04-12

Locations

4 sites across 1 country: China