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A clinical study for cancer stem cells exosome loaded dendritic cells vaccine and its activated CTL injection in the treatment of hepatic cell cancer and other solid tumors

A clinical study for cancer stem cells exosome loaded dendritic cells vaccine and its activated CTL injection in the treatment of hepatic cell cancer and other solid tumors

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020076
Enrollment
Unknown
Registered
2018-12-13
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatic cell cancer and other solid tumors

Interventions

DC vaccine group :DC vaccination therapy
CTL group :CTL infusion treatment
DC+CTL group:DC vaccination and CTL infution therapy
control group :no immune cellular therapy

Sponsors

Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old, male or female; 2. A HCC or other malignant solid tumor diagnosed by histology or cytology; 3. Auxiliary treatment after surgery or minimally invasive ablation; 4. Failed patients with first-line system chemotherapy, there are clinical evidences prove that disease progression 5. Patients who give up surgery or are not suitable for surgery; 6. According to therapeutic effect evaluation standard of solid tumor (RECIST1.1), with at least one measurable lesions, measurable lesions should be not received radiotherapy; 5. Stable situation in cardiac function, liver function and renal function; 6. ECOG Scoring Standard for Physical Status of Tumor Patients is ECOG 0-1; 7. No brain metastasis; Expected survival is longer than 12 months; 8. No blood components and growth factors were allowed to be used 2 weeks before the start of the study; 9. Women with fertility should be carried out within 72 hours of urine or serum pregnancy test before accepting first study drug dosage, and prove to negative, and willing to use effective methods of contraception during the study. For male subjects with a partner of childbearing age, effective method of contraception should be adopted during the study; 10. Patients have the ability to understand and voluntarily sign informed consent.?patients be able to follow the research and follow-up procedures to provide real and effective information.

Exclusion criteria

Exclusion criteria: 1. History of allergy to biological agents; 2. Metastasis of tumors to the central nervous system; 3. women who are lactating and gestation, and those who cannot take contraceptive measures during the course of treatment; 4. Subjects with congenital or acquired immunodeficiency (such as HIV infection, active hepatitis B); 5. With history of organ transplantation; 6. Any uncontrollable clinical problems (such as severe mental, neurological, cardiovascular, respiratory and other systemic diseases); 7. Cognitive ability and psychological abnormality; 8. Researchers believe that subjects may not be able to complete the study or may not be able to comply with the requirements of the study (due to management or other reasons).

Design outcomes

Primary

MeasureTime frame
ORR;PFS;mOS;EORTC;Tumor burden;Tumor makers;Detection of immunocyte subtypes;AEs;

Countries

China

Contacts

Public ContactZhao Zhenlin

Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine

zhaozl2006@163.com+86 13828895409

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026