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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    48
  • sponsor
    Fudan University
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Updated on 17 June 2022
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carcinoma
chemotherapy regimen
nasopharyngeal carcinoma
camrelizumab
metastatic nasopharyngeal carcinoma

Summary

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.

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.

Details
Condition Nasopharyngeal Carcinoma, Nasopharyngeal Cancer
Treatment Fluzoparib and Camrelizumab
Clinical Study IdentifierNCT04978012
SponsorFudan University
Last Modified on17 June 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Hypersensitivity to Fluzoparib or Camrelizumab
Symptomatic spinal cord compression, or high-risk to develop pathological fracture that requires urgent surgery or radiation
Necrotic disease, high-risk of massive bleeding
Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years
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
Previous treatment of PD-1/L1 inhibitors, CTLA-4 inhibitors, other checkpoint inhibitors or immune modulation therapy, or PARP inhibitors
Receive vaccine or live vaccine within 28 days prior to signing the informed consent
Still suffered from adverse effect (more than CTCAE grade 1), that results from previous treatment
Severe, uncontrolled infections within 28 days prior to signing inform consent
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
HIV positive
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
Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA
History of drug abuse, drug taking, alcohol abuse
Other diseases which may influence the safety or compliance of the clinical trial, such as mental illness, or their family and society factors
Women of child-bearing potential who are pregnant or breastfeeding
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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