Fluzoparib and Camrelizumab in Treating Patients With R/M NPC That Progressed After First-line Chemotherapy
NCT ID: NCT04978012
Last Updated: 2022-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
48 participants
INTERVENTIONAL
2021-07-25
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combination of Fluzoparib and Camrelizumab
Fluzoparib,150mg bid po, d1-21, q3w Camrelizumab 200mg iv, d1, q3w
Fluzoparib and Camrelizumab
Maintenance therapy of Fluzoparib and Camrelizumab, until disease progression or intolerable adverse effect.
Interventions
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Fluzoparib and Camrelizumab
Maintenance therapy of Fluzoparib and Camrelizumab, until disease progression or intolerable adverse effect.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Chaosu Hu
M.D., Professor
Principal Investigators
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Chaosu Hu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan Universtiy Shanghai Cancer Centre
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Wang FH, Wei XL, Feng J, Li Q, Xu N, Hu XC, Liao W, Jiang Y, Lin XY, Zhang QY, Yuan XL, Huang HX, Chen Y, Dai GH, Shi JH, Shen L, Yang SJ, Shu YQ, Liu YP, Wang W, Wu H, Feng H, Yao S, Xu RH. Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (POLARIS-02). J Clin Oncol. 2021 Mar 1;39(7):704-712. doi: 10.1200/JCO.20.02712. Epub 2021 Jan 25.
Ma BBY, Lim WT, Goh BC, Hui EP, Lo KW, Pettinger A, Foster NR, Riess JW, Agulnik M, Chang AYC, Chopra A, Kish JA, Chung CH, Adkins DR, Cullen KJ, Gitlitz BJ, Lim DW, To KF, Chan KCA, Lo YMD, King AD, Erlichman C, Yin J, Costello BA, Chan ATC. Antitumor Activity of Nivolumab in Recurrent and Metastatic Nasopharyngeal Carcinoma: An International, Multicenter Study of the Mayo Clinic Phase 2 Consortium (NCI-9742). J Clin Oncol. 2018 May 10;36(14):1412-1418. doi: 10.1200/JCO.2017.77.0388. Epub 2018 Mar 27.
Lung RW, Hau PM, Yu KH, Yip KY, Tong JH, Chak WP, Chan AW, Lam KH, Lo AK, Tin EK, Chau SL, Pang JC, Kwan JS, Busson P, Young LS, Yap LF, Tsao SW, To KF, Lo KW. EBV-encoded miRNAs target ATM-mediated response in nasopharyngeal carcinoma. J Pathol. 2018 Apr;244(4):394-407. doi: 10.1002/path.5018. Epub 2018 Feb 16.
Tatfi M, Hermine O, Suarez F. Epstein-Barr Virus (EBV)-Related Lymphoproliferative Disorders in Ataxia Telangiectasia: Does ATM Regulate EBV Life Cycle? Front Immunol. 2019 Jan 4;9:3060. doi: 10.3389/fimmu.2018.03060. eCollection 2018.
Other Identifiers
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NPC-PAPRi 1.0
Identifier Type: -
Identifier Source: org_study_id
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