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Autologous Cytokine-Induced Killer Cell Transfusion in Combination With Gemcitabine Plus Cisplatin Regimen Chemotherapy for Metastatic Nasopharyngeal Carcinoma


Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Stage IV Nasopharyngeal Carcinoma

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Trial Information

Autologous Cytokine-Induced Killer Cell Transfusion in Combination With Gemcitabine Plus Cisplatin Regimen Chemotherapy for Metastatic Nasopharyngeal Carcinoma


Inclusion Criteria:



1. The primary lesions of all patients were classified as undifferentiated,
non-keratinizing carcinoma at the initial stage for treatment (WHO, 1991 criteria)
and no distant metastasis was observed based on imaging studies before radiotherapy ;

2. all patients had received standard doses of radiotherapy, were regularly followed-up
after radiotherapy, and had distant metastatic lesions revealed by imaging studies;

3. metastases were found more than 6 months after the end of radiotherapy, with the
expected survival time of more than 3 months;

4. in each case, no more than 10 metastatic lesions were found in the imaging studies;

5. Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;

6. the bone marrow functioned normally (WBC > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L);

7. the ECG results were normal, and the liver and kidney were functional.

Exclusion Criteria:

1. Patients were excluded if they had central nervous system metastases;

2. uncontrolled infection; underlying disease that was severe or life-threatening;

3. the patients were pregnant or lactating;

4. ECOG perform status ≥ 2;

5. the patients who are suffering from auto immune diseases or patients who need to
accept glucocorticoid treatment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission (CR)

Outcome Description:

(According to the response criteria in solid tumor(RECIST), version 1.1) Complete remission (CR):Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial remission (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study ; Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome Time Frame:

Participants will accept 4cycles GC regimen chemotherapy (every 4 weeks) plus 8 cycles CIK cells treatment (every 4 weeks), a total of therapy time will be 12 months.

Safety Issue:

Yes

Principal Investigator

Jian-jun Li, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Food and Drug Administration

Study ID:

20120704

NCT ID:

NCT01655628

Start Date:

July 2012

Completion Date:

December 2014

Related Keywords:

  • Stage IV Nasopharyngeal Carcinoma
  • nasopharyngeal carcinoma
  • metastasis
  • gemcitabine
  • CIK cells
  • Carcinoma
  • Nasopharyngeal Neoplasms

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