By Using Adoptive Transfer of Autologous NK Cells to Prevent Recurrence of Hepatocellular Carcinoma After Curative Therapy

Hepatocellular Carcinoma Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02725996
• Other study ID #: TMMU-BTC-006
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 28, 2016
• Last updated: April 24, 2017
• Start date: April 2016
• Est. completion date: April 2019

Study information

• Verified date: March 2016
• Source: Southwest Hospital, China
• Contact: Cheng Qian, MD, PhD
• Phone: 0086-023-68765461
• Email: cqian3184[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To prove that the efficacy and safety of 'NK group' is superior to 'non-treatment group(Control group)' in patient undergone curative resection(RFA or operation) for hepatocellular carcinoma in China.

Description:

No adjuvant therapy has been shown to extend the survival of patients with hepatocellular carcinoma receiving curative treatment.We investigated whether injections of NK cells prolongs recurrence-free survival of patients after curative therapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: April 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Prior to the test, patient is fully explained about the purpose/ contents and characteristics of the testing medication, and the patient him(her)self, the guardian or the legal representative signed on written consent.

2. Gender unlimited, age from 18 years to 70 years

3. The patient is diagnosed as hepatocellular carcinoma by pathological/ radiological test and he (she) is in the stage of I or II. (refer to the attached file 10). Hepatocellular carcinoma should be shown by radiological test; on dynamic CT, dynamic MRI or on angiography.

4. Child-Pugh Score should be less than 6

5. No matter how the patient has been treated before, his (her) tumor should be totally removed by curative resection (RFA or operation). (based on the agreement date for written consent)

6. Patients must have adequate cardiac function(no cardiac disease, LVEF=40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr=133umol/L).

7. Patient's remaining life-time should be expected at least more than 3 months.

Exclusion Criteria:

1. Hepatocellular carcinoma has been transferred by pathological/ radiological test (Stage III or Stage IV, refer to the exhibit 10)

2. The carcinoma has been invaded to main portal vein or major branch hepatic vein

3. Child-Pugh score is over 6

4. Patient has serious problem with pulmonary function by sub- investigator's opinion

5. Patient who has disease history of immune deficiency

6. Diagnosed as an immune deficiency patient

7. Patient who has disease history of malignant tumor within 5 years before this clinical trial.

8. Patient who had anti-cancer medication before the clinical trial

9. Patient has serious allergic-history by sub- investigator's opinion

10. Patient has serious mental disease by sub- investigator's opinion

11. Pregnant women, nursing mother or having intention of being pregnant during the clinical test

12. Patient who participated in other clinical trial within 4 weeks before this clinical trial

13. Patient who is incongruent to this clinical trial by sub- investigator's opinion.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• NK cells
Adjuvant adoptive immune therapy using NK cell 4 times

Other:
• Curative therapy
Patients who had undergone curative treatment(surgical resection or radiofrequency ablation for HCC of pretreatment clinical stage I or II were eligible for this study with no adjuvant treatment

Locations

Country	Name	City	State
China	Southwest Hospital of Third Millitary Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence Free Survival(RFS) :RFS was measured from the date of randomization to the first recurrence or to death from any cause.		3 years
Primary	Overall Survival(OS) :Overall survival was measured from the date of randomization until death from any cause.		3 years