Fluzoparib and Camrelizumab in Treating Patients With R/M NPC That Progressed After First-line Chemotherapy

June 4, 2022 updated by: Chaosu Hu, Fudan University

A Phase II Single-site the Study of the Efficacy and Safety of Fluzoparib and Camrelizumab in Treating Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma That Progressed After First-line Chemotherapy

The aim of this study is to define the efficacy and safety of Fluzoparib and Camrelizumab in treating patients with recurrent/metastatic nasopharyngeal carcinoma that progressed after first-line chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Currently, the standard first-line treatment for recurrent/metastatic nasopharyngeal carcinoma is cisplatin-based chemotherapy. The recommended subsequent line therapy is single-agent chemotherapy or single-agent PD-1 antibody (nivolumab or pembrolizumab), according to NCCN guidelines (head and neck cancer, version 2021.3). However, the efficacy of nivolumab or pembrolizumab in subsequent line setting is limited, range from 20-30%. In order to improve the efficacy, we launch this study to evaluate whether combination treatment of PARP inhibitor (Fluzoparib) and PD-1 antibody (Camrelizumab) has the potential to increase efficacy in the subsequent line treatment, meanwhile has tolerable adverse effect.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chaosu Hu, M.D.
  • Phone Number: 81400 +8621-64175590
  • Email: hucsu62@163.com

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan Universtiy Shanghai Cancer Centre
        • Contact:
          • Chaosu Hu, M.D.
          • Phone Number: 81400 +8621-64175590
          • Email: hucsu62@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Sign an informed consent;
  2. Age older than 18 years old and younger than 75 years old;
  3. Patients with histologically confirmed recurrent/metastatic nasopharyngeal carcinoma, that progressed after at least first-line chemotherapy, according to RECIST 1.1 criteria;
  4. No previous treatment of PD-1/L1 inhibitors, CTLA-4 inhibitors, other checkpoint inhibitors or immune modulation therapy, or PARP inhibitors;
  5. At least one lesion that fulfills the criteria of "Evaluable Disease" per RECIST 1.1 Criteria;
  6. Anticipated overall survival more than 3 months;
  7. Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-2;
  8. Normal organ function;
  9. HBV DNA<500 IU/mL（or 2500 copies/mL）and HCV RNA negative ;
  10. Male and no pregnant female, able to adapt birth control methods during treatment.

Exclusion Criteria:

  1. Hypersensitivity to Fluzoparib or Camrelizumab;
  2. Symptomatic spinal cord compression, or high-risk to develop pathological fracture that requires urgent surgery or radiation;
  3. Necrotic disease, high-risk of massive bleeding;
  4. Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years;
  5. Severe, uncontrolled heart disease, such as more than NYHA II heart failure, unstable angina pectoris, myocardial infarction within 1 year prior to signing inform consent, severe arrhythmia that requires urgent intervention;
  6. Previous treatment of PD-1/L1 inhibitors, CTLA-4 inhibitors, other checkpoint inhibitors or immune modulation therapy, or PARP inhibitors;
  7. Receive vaccine or live vaccine within 28 days prior to signing the informed consent;
  8. Still suffered from adverse effect (more than CTCAE grade 1), that results from previous treatment;
  9. Severe, uncontrolled infections within 28 days prior to signing inform consent;
  10. Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, vitiligo or inactive asthma who don't need systemic therapy can recruit;
  11. HIV positive;
  12. Diagnosed as active pulmonary tuberculosis within one year before signing inform consent; or diagnosed as active pulmonary tuberculosis more than one year, but did not receive standardized anti-tuberculosis treatment;
  13. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA;
  14. History of drug abuse, drug taking, alcohol abuse;
  15. Other diseases which may influence the safety or compliance of the clinical trial, such as mental illness, or their family and society factors;
  16. Women of child-bearing potential who are pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Combination of Fluzoparib and Camrelizumab
Fluzoparib,150mg bid po, d1-21, q3w Camrelizumab 200mg iv, d1, q3w
Drug: Fluzoparib and Camrelizumab
Maintenance therapy of Fluzoparib and Camrelizumab, until disease progression or intolerable adverse effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: Within 2 year post-treatment
Overall response rate, evaluated by independent radiology review board, according to RECIST 1.1 Criteria
Within 2 year post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate
Time Frame: Within 2 year post-treatment
Disease control rate, evaluated by independent radiology review board, according to RECIST 1.1 Criteria
Within 2 year post-treatment
Duration of response
Time Frame: Within 2 year post-treatment
Duration of response, evaluated by independent radiology review board, according to RECIST 1.1 Criteria
Within 2 year post-treatment
Progression-free survival rate at 6 month post-treatment
Time Frame: 6 month post-treatment
Progression-free survival rate at 6 month post-treatment
6 month post-treatment
Overall survival rate at 6 month post-treatment
Time Frame: 6 month post-treatment
Overall survival rate at 6 month post-treatment
6 month post-treatment
Progression-free survival rate at 12 month post-treatment
Time Frame: 12 month post-treatment
Progression-free survival rate at 12 month post-treatment
12 month post-treatment
Overall survival rate at 12 month post-treatment
Time Frame: 12 month post-treatment
Overall survival rate at 12 month post-treatment
12 month post-treatment
Median progression-free survival
Time Frame: Within 2 year post-treatment
Median progression-free survival
Within 2 year post-treatment
Median overall survival
Time Frame: Within 2 year post-treatment
Median overall survival
Within 2 year post-treatment
Adverse effect
Time Frame: Within 2 year post-treatment
Adverse effect, according to CTCAE 4.0.03 criteria
Within 2 year post-treatment
Overall response rate by different PD-L1 TPS subgroups
Time Frame: Within 2 year post-treatment
Overall response rate by different PD-L1 TPS subgroups (≥1% vs. <1%; ≥20% vs. <20%; ≥50% vs. <50%）)
Within 2 year post-treatment
Overall response rate by different homologous recombination repair status (HRR)
Time Frame: Within 2 year post-treatment
Overall response rate by different homologous recombination repair status(germline BRCA mutation/wildtype, HRD positive/negative, germline HRR genes mutations status)
Within 2 year post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Chaosu Hu, M.D., Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 25, 2021

Primary Completion (ANTICIPATED)

December 31, 2024

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

July 25, 2021

First Submitted That Met QC Criteria

July 25, 2021

First Posted (ACTUAL)

July 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 4, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-PAPRi 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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