A Clinical Study of Chemoradiotherapy Sequential Fluzoparib in Pan-solid Tumors
- Sponsor
- Chongqing University Cancer Hospital
- Study ID
- NCT06055166
- Phase
- PHASE2
- Status
- Unknown
Conditions
- PARP Inhibitor for Esophageal Squamous Cell Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) — DRUGArm 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
Study Details
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.
Key Dates
- Start date
- Nov 1, 2023
- Status verified
- Jul 2023
- Primary completion
- Nov 30, 2024
- Completion
- May 31, 2026
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: untreated surgically resectable rectal cancer
- Experimental: untreated locally advanced unresectable non-small cell lung cancer
- Experimental: untreated locally advanced unresectable esophageal squamous cell carcinoma
- Experimental: untreated locally advanced unresectable cervical carcinoma
Primary Outcome Measure
pCR [ Time Frame: within 14 working days after operation ]