Phase II Trial of TIL Following CCRT in Patients With Locoregionally Advanced NPC (TIL)
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|ClinicalTrials.gov Identifier: NCT02421640|
Recruitment Status : Recruiting
First Posted : April 20, 2015
Last Update Posted : October 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Drug: Cisplatin+TIL Drug: Cisplatin||Phase 2|
Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. For locoregionally advanced NPC,especially for the high risk NPC (EB virus DNA ≥ 4000 copies/ml) ,the incidence of treatment failure is still high. Although concurrent chemoradiotherapy (CCRT) can improve the treatment outcomes of these patients, approximately 25% of locoregionally advanced NPCs relapse. Adjuvant chemotherapy or inducing chemotherapy addition to CCRT did not significantly improve patient survival compared to CCRT alone. Hence, there is an urgent need for novel therapies to improve disease-free survival and reduce treatment-related toxicity in patients.
Accumulating evidence shows that tumor-infiltrating lymphocytes (TILs) selected for tumor recognition and greatly expanded in vitro are especially effective for treating cancer patients.The investigations phase I results showed that TILs following CCRT as a novel treatment strategy in locoregionally advanced NPC patients resulted in sustained anti-tumor activity and anti-EBV immune responses, associated with a good tolerance.
This is a Phase II trial to study the effectiveness and security of cisplatin CCRT plus TIL versus cisplatin CCRT only with IMRT in treating patients with locoregionally advanced high risk NPC.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes and Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2020|
Cisplatin concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL)
cisplatin 100mg/m2(every three weeks),D1,D22,D43 of radiotherapy,then TIL infusing following concurrent chemoradiotherapy
Other Name: DDP
Active Comparator: Cisplatin
Cisplatin concurrent chemoradiotherapy(CCRT) only
cisplatin 100mg/m2(every three weeks),D1,D22,D43 of radiotherapy only
Other Name: DDP
- Progress-free survival [ Time Frame: 3 years ]Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
- Overall Survival (OS) [ Time Frame: 3 years ]The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
- Locoregional Relapse-Free Survival (LRRF) [ Time Frame: 3 years ]The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.
- Distant Metastasis-Free Survival (DMFS) [ Time Frame: 3 years ]The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
- Complete Response (CR) [ Time Frame: after the completion of the chemoradiotherapy treatment (up to 9 weeks) ]CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
- Determine the toxic effects in these patients. [ Time Frame: 4 weeks ]Patients will be monitored for clinical toxicity by standard NIH criteria. A time period of 4 weeks will constitute the time for clinical safety monitoring.
- Determine the molecular expression of EBV DNA. [ Time Frame: 12 weeks ]The molecular expression responses of the patients, including their plasma EBV DNA load, IFN levels and the expansion of EBV-antigen specific T cells.
- Determine the quality of life (QoL) of these regimens in these patients. [ Time Frame: 4 weeks ]Administration and Monitoring Patients will be evaluated in the clinic and eligibility and informed consent obtained. QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) and EORTC QLQ Head and Neck.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421640
|Contact: Qiuyan Chen, MD,PhDfirstname.lastname@example.org|
|Guangzhou, Guangdong, China, 510060|
|Contact: Qiuyan Chen, MD,PhD 86-20-87343380 email@example.com|
|Principal Investigator:||Haiqiang Mai, MD,PhD||Cancer center|