Phase II Trial of TIL Following CCRT in Patients With Locoregionally Advanced NPC

NCT02421640 | Unknown Phase 2 DMC

• 1 other identifier: NPC and TIL
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progress-free survival

  Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.

  3 years

Secondary Outcomes (7)

• Overall Survival (OS)

  3 years

• Locoregional Relapse-Free Survival (LRRF)

  3 years

• Distant Metastasis-Free Survival (DMFS)

  3 years

• Complete Response (CR)

  after the completion of the chemoradiotherapy treatment (up to 9 weeks)

• Determine the toxic effects in these patients.

  4 weeks

Study Arms (2)

Cisplatin+TIL

EXPERIMENTAL

Cisplatin concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL)

Drug: Cisplatin+TIL

Cisplatin

ACTIVE COMPARATOR

Cisplatin concurrent chemoradiotherapy(CCRT) only

Drug: Cisplatin

Interventions

Cisplatin+TIL DRUG

cisplatin 100mg/m2(every three weeks),D1,D22,D43 of radiotherapy,then TIL infusing following concurrent chemoradiotherapy

Also known as: DDP

Cisplatin+TIL

Cisplatin DRUG

cisplatin 100mg/m2(every three weeks),D1,D22,D43 of radiotherapy only

Also known as: DDP

Cisplatin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Haiqiang Mai

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (12)

• Chan 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 BACKGROUND

• Zhang 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 BACKGROUND

• Baujat 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 BACKGROUND

• Chen 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 BACKGROUND

• Chen 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 BACKGROUND

• 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.

  PMID: 17135642 BACKGROUND

• Lin JC, Wang WY, Chen KY, Wei YH, Liang WM, Jan JS, Jiang RS. Quantification of plasma Epstein-Barr virus DNA in patients with advanced nasopharyngeal carcinoma. N Engl J Med. 2004 Jun 10;350(24):2461-70. doi: 10.1056/NEJMoa032260.

  PMID: 15190138 BACKGROUND

• Louis CU, Straathof K, Bollard CM, Ennamuri S, Gerken C, Lopez TT, Huls MH, Sheehan A, Wu MF, Liu H, Gee A, Brenner MK, Rooney CM, Heslop HE, Gottschalk S. Adoptive transfer of EBV-specific T cells results in sustained clinical responses in patients with locoregional nasopharyngeal carcinoma. J Immunother. 2010 Nov-Dec;33(9):983-90. doi: 10.1097/CJI.0b013e3181f3cbf4.

  PMID: 20948438 BACKGROUND

• Louis CU, Straathof K, Bollard CM, Gerken C, Huls MH, Gresik MV, Wu MF, Weiss HL, Gee AP, Brenner MK, Rooney CM, Heslop HE, Gottschalk S. Enhancing the in vivo expansion of adoptively transferred EBV-specific CTL with lymphodepleting CD45 monoclonal antibodies in NPC patients. Blood. 2009 Mar 12;113(11):2442-50. doi: 10.1182/blood-2008-05-157222. Epub 2008 Oct 29.

  PMID: 18971421 BACKGROUND

• Smith C, Tsang J, Beagley L, Chua D, Lee V, Li V, Moss DJ, Coman W, Chan KH, Nicholls J, Kwong D, Khanna R. Effective treatment of metastatic forms of Epstein-Barr virus-associated nasopharyngeal carcinoma with a novel adenovirus-based adoptive immunotherapy. Cancer Res. 2012 Mar 1;72(5):1116-25. doi: 10.1158/0008-5472.CAN-11-3399. Epub 2012 Jan 26.

  PMID: 22282657 BACKGROUND

• Dudley ME, Gross CA, Langhan MM, Garcia MR, Sherry RM, Yang JC, Phan GQ, Kammula US, Hughes MS, Citrin DE, Restifo NP, Wunderlich JR, Prieto PA, Hong JJ, Langan RC, Zlott DA, Morton KE, White DE, Laurencot CM, Rosenberg SA. CD8+ enriched "young" tumor infiltrating lymphocytes can mediate regression of metastatic melanoma. Clin Cancer Res. 2010 Dec 15;16(24):6122-31. doi: 10.1158/1078-0432.CCR-10-1297. Epub 2010 Jul 28.

  PMID: 20668005 BACKGROUND

• Liang YJ, Chen QY, Xu JX, Liu XF, Xia JC, Liu LT, Guo SS, Song B, Wang P, Li JB, Liu Q, Mo HY, Guo L, Sun R, Luo DH, He J, Liu YN, Nie CP, Tang LQ, Li J, Mai HQ. A phase II randomised controlled trial of adjuvant tumour-infiltrating lymphocytes for pretreatment Epstein-Barr virus DNA-selected high-risk nasopharyngeal carcinoma patients. Eur J Cancer. 2023 Sep;191:112965. doi: 10.1016/j.ejca.2023.112965. Epub 2023 Jul 5.

  PMID: 37540921 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Haiqiang Mai, MD,PhD

  Cancer center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiuyan Chen, MD,PhD

CONTACT

86-20-87343380; chenqy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Nasopharyngeal Carcinoma

Study Record Dates

• First Submitted: April 11, 2015
• First Posted: April 20, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2020
• Last Updated: October 18, 2016

Record last verified: 2016-09

Locations

CN (1)