NCT06055166

A Clinical Study of Chemoradiotherapy Sequential Fluzoparib in Pan-solid Tumors

A Prospective, Multi-cohort, Single-center Phase II Clinical Study of Chemoradiotherapy Sequential Fluzoparib in Pan-solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Chongqing University Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multi-cohort, single-centre, phase II clinical trial designed to initially explore the efficacy and safety of sequential fluzoparib with chemoradiotherapy in pan-solid tumours. The study is designed for patients with untreated surgically resectable rectal cancer and untreated locally advanced unresectable non-small cell lung cancer, oesophageal squamous cancer, and cervical cancer.

Conditions

• PARP Inhibitor for Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm))	Arm A: untreated surgically resectable rectal cancer. Patients accept preoperative long-range synchronous chemoradiotherapy → fluzoparib combined with capecitabine (Q3W, 4 treatment cycles) → surgery → observation and follow-up Arm B, C and D: include untreated locally advanced unresectable non-small cell lung cancer, esophageal squamous cell carcinoma and cervical carcinoma. Patients accept radical synchronous chemoradiotherapy following → fluzoparib combined with camrelizumab or fluzoparib monotherapy maintenance treatment for 17 cycles

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-11-30
• Completion: 2026-05-31
• First posted: 2023-09-26
• Last updated: 2023-09-26