Safety and Efficacy of Allogeneic NK Cells Therapy in Patients With Advanced Hepatocellular Carcinoma

NCT04162158 | Unknown Phase 1

• 1 other identifier: beijing302-NK-HCC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, open-label, paired control study to evaluate the safety and clinical efficacy of allogeneic NK cells combined with targeted drug in the treatment for advanced HCC.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events

  Incidence of Treatment-Emergent Adverse Events as assessed by \[National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0\]

  From the date of enrollment to the end of two years of follow-up.

• Overall survival

  Overall Survival (OS) defined as the time from randomisation until death by any cause. Participants will be followed up for survival follow up for at least five years.

  From the date of enrollment to the end of two years of follow-up.

Secondary Outcomes (1)

• Disease control rate

  From the date of enrollment to the end of two years of follow-up.

Study Arms (2)

Targeted drug combined with allogeneic NK cell treatment group

EXPERIMENTAL

In addition to traditional symptomatic supportive treatment, Sorafenib, regolfinib or levabinib will be administered in combination with allogeneic NK cells (3 cycles).

Biological: allogeneic NK cells therapy

Targeted drug treatment group

NO INTERVENTION

Sorafenib, regolfinib or levabinib will be administered in addition to traditional symptomatic supportive care.

Interventions

allogeneic NK cells therapy BIOLOGICAL

PBMC was isolated from the peripheral blood of the donors and infused to the patient after 14 days incubation. In each cycle, patients will be infused 4.0-5.0×10'9 allogeneic NK cells. All patients in the experimental group received a total of three cycles of treatment with one month interval between each treatment.

Targeted drug combined with allogeneic NK cell treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• According to the 2010 edition of the diagnostic criteria for primary liver cancer BCLC, the patient was diagnosed as advanced hepatocellular carcinoma by pathology and imaging (BCLC C phase);
• Child-Pugh A/B (5-9), Eastern Cooperative Oncology Group (ECOG) PS score less than 2 points;
• Laboratory criteria:
• Liver function: Child A/B, ALT \< 200 U/L, AST \< 200 U/L, Tbil \<51μmol/L
• Renal function: Creatinine clearance ≥ 60ml/minute
• Hematologic function: PLT ≥40×10'9/L, WBC ≥2×10'9/L, HGB\>80 g/L
• Cardiac function: No abnormality in cardiac enzyme and ECG
• Survival expectation is greater than 6 months;
• Patients with active hepatitis B or C were treated with the appropriate NA or DAA medication, and all patients enrolled in the group were treated with targeted drugs.
• The patient has a donor who meets the donor enrollment criteria and all patients and donors sign the Informed Consent Form;

You may not qualify if:

• Women who are pregnant or breast-feeding.
• Co-infected with hepatitis A, hepatitis E, AIDS or other infectious diseases.
• Patients with serious complications such as acute infection and gastrointestinal bleeding within 30 days.
• Patients with other serious systemic and psychiatric diseases.
• Exposure to any cell therapy such as, but not limited to CIK, DC, CTL , PD-1 and stem cells therapy 6 months prior to study drug administration.
• Other conditions that researchers believe may increase the risk of subjects or lead to affected study results, such as the presence of mental illness in subjects.

Sponsors & Collaborators

• Beijing 302 Hospital: lead
• Shenzhen Third People's Hospital: collaborator
• The first People's Hospital of Zhengzhou: collaborator

Study Sites (1)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Fusheng Wang

  Beijing 302 Hospital

  STUDY CHAIR

Central Study Contacts

Junliang Fu

CONTACT

010-66-933332; fjunliang@163.com

Yunbo Xie

CONTACT

010-66-933331; 15110140963@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: November 14, 2019
• Study Start: March 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2024
• Last Updated: November 14, 2019

Record last verified: 2019-04

Locations

CN (1)