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

NCT ID: NCT02421640

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2020-03-31

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.

Detailed Description

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cisplatin+TIL

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

Group Type: EXPERIMENTAL

Cisplatin+TIL

Intervention Type: DRUG

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

Cisplatin

Cisplatin concurrent chemoradiotherapy(CCRT) only

Group Type: ACTIVE_COMPARATOR

Cisplatin

Intervention Type: DRUG

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

Interventions

Cisplatin+TIL

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

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Other Intervention Names

DDP; DDP

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Hai-Qiang Mai,MD,PhD

Deputy Director of the Department of Nasopharyngeal Carcinoma

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haiqiang Mai, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Cancer center

Locations

Haiqiang Mai

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiuyan Chen, MD,PhD

Role: CONTACT

chenqy@sysucc.org.cn

86-20-87343380

Facility Contacts

Qiuyan Chen, MD,PhD

Role: primary

chenqy@sysucc.org.cn

86-20-87343380

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Other Identifiers

NPC and TIL

Identifier Type: -

Identifier Source: org_study_id