Clinical trial · Interventional
Phase II Trial of TIL Following CCRT in Patients With Locoregionally Advanced NPC
A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes and Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma
NCT02421640CI-TRIAL-00024335TILunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase II trial to study the effectiveness and security of cisplatin concurrent chemoradiotherapy plus TIL versus cisplatin concurrent chemoradiotherapy only with IMRT in treating patients with locoregionally advanced high risk nasopharyngeal carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Cisplatin+TIL | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cisplatin+TIL
- description
- Cisplatin concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL)
- interventionNames
- Drug: Cisplatin+TIL
- type
- ACTIVE_COMPARATOR
- label
- Cisplatin
- description
- Cisplatin concurrent chemoradiotherapy(CCRT) only
- interventionNames
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Progress-free survival
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III * Original clinical staged as T3-4N1-3 M0 or any T、N2-3M0（according to the 7th AJCC edition） * No evidence of distant metastasis (M0) * Plasm EB Virus DNA≥4000copies/ml * Male and no pregnant female * Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1 * WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L * With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN) * With normal renal function test (Creatinine ≤ 1.5×ULN) Exclusion Criteria: * Patients have evidence of relapse or distant metastasis * Histologically confirmed keratinizing squamous cell carcinoma (WHO I) * Receiving radiotherapy or chemotherapy previously * The presence of uncontrolled life-threatening illness * Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. * Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease. * Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). * Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). * Concurrent systemic steroid therapy * HIV positive * Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously
References
Publications (12)
- BACKGROUNDChan AT, Leung SF, Ngan RK, Teo PM, Lau WH, Kwan WH, Hui EP, Yiu HY, Yeo W, Cheung FY, Yu KH, Chiu KW, Chan DT, Mok TS, Yau S, Yuen KT, Mo FK, Lai MM, Ma BB, Kam MK, Leung TW, Johnson PJ, Choi PH, Zee BC. Overall survival after concurrent cisplatin-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma. J Natl Cancer Inst. 2005 Apr 6;97(7):536-9. doi: 10.1093/jnci/dji084. PMID 15812080
- BACKGROUNDZhang L, Chen QY, Liu H, Tang LQ, Mai HQ. Emerging treatment options for nasopharyngeal carcinoma. Drug Des Devel Ther. 2013;7:37-52. doi: 10.2147/DDDT.S30753. Epub 2013 Feb 1. PMID 23403548
- BACKGROUNDBaujat B, Audry H, Bourhis J, Chan AT, Onat H, Chua DT, Kwong DL, Al-Sarraf M, Chi KH, Hareyama M, Leung SF, Thephamongkhol K, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy in locally advanced nasopharyngeal carcinoma: an individual patient data meta-analysis of eight randomized trials and 1753 patients. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):47-56. doi: 10.1016/j.ijrobp.2005.06.037. PMID 16377415
- BACKGROUNDChen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J. Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial. Lancet Oncol. 2012 Feb;13(2):163-71. doi: 10.1016/S1470-2045(11)70320-5. Epub 2011 Dec 7. PMID 22154591
- BACKGROUNDChen QY, Wen YF, Guo L, Liu H, Huang PY, Mo HY, Li NW, Xiang YQ, Luo DH, Qiu F, Sun R, Deng MQ, Chen MY, Hua YJ, Guo X, Cao KJ, Hong MH, Qian CN, Mai HQ. Concurrent chemoradiotherapy vs radiotherapy alone in stage II nasopharyngeal carcinoma: phase III randomized trial. J Natl Cancer Inst. 2011 Dec 7;103(23):1761-70. doi: 10.1093/jnci/djr432. Epub 2011 Nov 4. PMID 22056739
- Leung SF, Zee B, Ma BB, Hui EP, Mo F, Lai M, Chan KC, Chan LY, Kwan WH, Lo YM, Chan AT. Plasma Epstein-Barr viral deoxyribonucleic acid quantitation complements tumor-node-metastasis staging prognostication in nasopharyngeal carcinoma. J Clin Oncol. 2006 Dec 1;24(34):5414-8. doi: 10.1200/JCO.2006.07.7982.