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Angiogenesis Inhibitor

Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors

Phase 1
Waitlist Available
Led By Huiping Li, M.D.
Research Sponsored by Beijing Cancer Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 1 year
Awards & highlights
No Placebo-Only Group

Summary

Homologous Recombination Repair (HRR) gene mutations can be detected in many solid tumors, patients with HRR gene mutations may benefit from PARP inhibitor. Antiangiogenic drugs can induce hypoxia and increase the sensitivity to PARP inhibitor. The combination of PARP inhibitor and antiangiogenic drug can play a synergistic anti-tumor role and achieve good efficacy in HRR gene-mutated tumors. The purpose of the study is to determine the dose limiting toxicity (DLT) and maximum tolerable dose (MTD) of Niraparib plus Anlotinib in HRR gene-mutated advanced solid tumors, and evaluate the safety and effectiveness of this combination therapy preliminarily.

Eligible Conditions
  • Cholangiocarcinoma
  • Bile Duct Cancer
  • Breast Cancer
  • Stomach Cancer
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Objective Response Rate (ORR)
Progression-free survival (PFS)
The frequency and severity of adverse events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment2 Interventions
Niraparib-Anlotinib combination therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
FDA approved
Anlotinib
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Beijing Cancer HospitalLead Sponsor
125 Previous Clinical Trials
32,596 Total Patients Enrolled
Peking University Cancer Hospital & InstituteLead Sponsor
349 Previous Clinical Trials
714,789 Total Patients Enrolled
1 Trials studying Cholangiocarcinoma
24 Patients Enrolled for Cholangiocarcinoma
Huiping Li, M.D.Principal InvestigatorPeking University Cancer Hospital & Institute
Jiafu Ji, M.D.Principal InvestigatorPeking University Cancer Hospital & Institute
4 Previous Clinical Trials
566 Total Patients Enrolled
~11 spots leftby Dec 2025
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