Overview

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

Status:
Unknown status
Trial end date:
2020-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Treatments:
Cisplatin
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