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

NCT06055166 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-09-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Chongqing University Cancer Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-11-30
Completion
2026-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06055166 on ClinicalTrials.gov