Niraparib And Sintilimab In Recurrent/Metastatic Nasopharyngeal Carcinoma

Status Recruiting

Clinical Trial Summary

this study is aimed to evaluate the efficacy and safety of the combination of Niraparib and Sintilimab in the treatment of recurrent/metastatic nasopharyngeal carcinoma

Clinical Trial Description

this is a phase II, open-label study, to see whether the combination of Niraparib and Sintilimab is effective and safe to treat recurrent/metastatic nasopharyngeal carcinoma. we will enroll patients who are histologically confirmed recurrent or metastatic nasopharyngeal carcinoma (including recurrence and metastasis after radiotherapy, or a condition not suitable for surgery and radiotherapy judged by investigator) ≥ 1L of platinum-based chemotherapy, at least 1 measurable lesion (RECIST 1.1), ECOG 0-1. the study is designed to contain 2 cohorts: cohort A PD-(L)1 naive and cohort B PD-(L)1 previously treated patients, simon 2-steps design for each cohort, that is: for cohort A, first step will enroll 23 patients, if CR/PR patients ≥3， then go to the second step, continue to enroll 39 patients, otherwise this cohort ends. for cohort B, first step enroll 20 patients, if CR/PR patients ≥1，then continue to enroll 17 patients, otherwise the cohort ends. Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage associated with nasopharyngeal carcinoma from occurring. The FDA has not approved niraparib for nasopharyngeal carcinoma, but it has been approved for other uses. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05162872
Study type	Interventional
Source	Sun Yat-sen University
Contact	Li zhang, Doctor
Phone	+8613902282893
Email	zhangli@sysucc.org.cn
Status	Recruiting
Phase	Phase 2
Start date	August 5, 2021
Completion date	October 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05979961` - Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma	Phase 3
Active, not recruiting	`NCT04242199` - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors	Phase 1
Recruiting	`NCT05415098` - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas	Phase 1
Recruiting	`NCT06055816` - Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma	Phase 2
Recruiting	`NCT05547971` - Development of Intelligent Model for Radioactive Brain Damage of Nasopharyngeal Carcinoma Based on Radio-metabolomics
Not yet recruiting	`NCT05020925` - SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma	Phase 1/Phase 2
Not yet recruiting	`NCT04548271` - Camrelizumab Combined With Apatinib in Patients With PD-1 Antagonists Resistant Recurrent/Metastatic Nasopharyngeal Carcinoma	Phase 2
Not yet recruiting	`NCT04547088` - Camrelizumab Combined With Apatinib in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma	Phase 2
Recruiting	`NCT02795169` - Trail Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma	Phase 1/Phase 2
Terminated	`NCT02801487` - Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma	Phase 1/Phase 2
Terminated	`NCT02569788` - Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma	Phase 1/Phase 2
Completed	`NCT02237924` - Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma	Phase 2
Recruiting	`NCT02044562` - Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients	N/A
Terminated	`NCT01694576` - NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation	Phase 2
Recruiting	`NCT01462903` - A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors	Phase 1
Completed	`NCT01271439` - Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma	Phase 2
Completed	`NCT00535795` - Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA	Phase 3
Completed	`NCT00379262` - Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma	Phase 3
Completed	`NCT03398980` - Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy	N/A
Completed	`NCT01309633` - Study Evaluating Two Loading Regimens of Sunitinib or Bevacizumab Alternating With Cisplatin and Gemcitabine as Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma (NPC)	Phase 2