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

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

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.