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

Launched by FUDAN UNIVERSITY · Jul 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two medications, Fluzoparib and Camrelizumab, to see how effective and safe they are for treating patients with recurrent or metastatic nasopharyngeal carcinoma (a type of throat cancer) that has returned or spread after initial chemotherapy. The goal is to find out if this new treatment can help improve the health of patients who have not had good results from previous treatments.

To participate in this trial, patients must be between 18 and 75 years old and have a confirmed diagnosis of nasopharyngeal carcinoma that has progressed after at least one round of chemotherapy. They should not have previously received certain types of immune therapies or medications related to this study. Participants can expect to be monitored closely for their health and any side effects while receiving this treatment. It’s important for potential participants to know that they will need to meet specific health criteria and may be required to use birth control during the study if they are capable of becoming pregnant.

Gender

ALL

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.