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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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