Combining Fluzoparib and Camrelizumab for advanced nasopharyngeal cancer after chemotherapy

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

This study is testing a new combination of two drugs, Fluzoparib and Camrelizumab, to see if they can help people with advanced nasopharyngeal cancer who haven't responded well to previous chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: Camrelizumab, chemotherapy, radiation, nivolumab, pembrolizumab
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT04978012 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of a combination treatment using Fluzoparib, a PARP inhibitor, and Camrelizumab, a PD-1 antibody, in patients with recurrent or metastatic nasopharyngeal carcinoma who have progressed after first-line chemotherapy. The research is motivated by the limited effectiveness of current therapies, which typically yield a response rate of only 20-30%. By combining these two agents, the study seeks to enhance treatment outcomes while maintaining manageable side effects. Participants will be closely monitored for their response to the treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with histologically confirmed recurrent or metastatic nasopharyngeal carcinoma who have progressed after at least one line of chemotherapy.

Not a fit: Patients who have previously received PD-1/L1 inhibitors, CTLA-4 inhibitors, or PARP inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with advanced nasopharyngeal cancer who have limited treatment choices.

How similar studies have performed: While the combination of PARP inhibitors and PD-1 inhibitors is a novel approach, similar studies have shown promise in other cancer types, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai

• Fudan Universtiy Shanghai Cancer Centre — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Chaosu Hu, M.D. — Fudan University
• Study coordinator: Chaosu Hu, M.D.

Conditions Nasopharyngeal Carcinoma; Nasopharyngeal Cancer; PARP inhibitor; Fluzoparib; checkpoint inhibitor; PD-1 inhibitor; Camrelizumab