Microtransplantation for treating advanced solid tumors

Efficacy and Safety of Radiotherapy or Chemotherapy Combined With Microtransplantation in the Treatment of Advanced and Relapsed Solid Tumors

This study is testing if adding a special type of stem cell treatment to regular chemotherapy and radiation can help people with advanced solid tumors feel better and improve their chances of recovery.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT04937842 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of combining microtransplantation with conventional chemotherapy and radiotherapy for patients with advanced or relapsed solid tumors. Eligible participants will be assigned to either the experimental group, receiving peripheral blood hematopoietic stem cells from HLA mismatched donors after standard treatment, or the control group, which will only receive conventional therapies. Treatment plans will be individualized based on thorough evaluations by a team of oncologists, and efficacy will be assessed after each treatment cycle. Patients who do not show improvement after two cycles will be withdrawn from the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with advanced or relapsed solid tumors who have suitable hematopoietic stem cell donors.

Not a fit: Patients without suitable donors or those who refuse donor cells may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option that enhances the effectiveness of existing therapies for patients with advanced solid tumors.

How similar studies have performed: While the concept of microtransplantation is emerging, this specific approach in the context of solid tumors is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Patients are 18-80 years old, regardless of gender or race;
* Advanced / relapsed solid tumors (small cell lung cancer, ovarian cancer, cervical cancer, gastric and colorectal cancer, sarcoma, head and neck tumor, etc.) are confirmed by clinical or histopathological diagnosis;
* More than two kinds of tumors are allowed;
* Karnofsky score ≥ 60, ECoG physical status ≤ 2;
* Sensitive to chemotherapy or radiotherapy;
* There are measurable lesions;
* There are suitable hematopoietic stem cell donors

Exclusion Criteria:

* have no suitable donor or donor refused
* patient refused to accept donor cells

Where this trial is running

Beijing, Beijing

• Beijing Fengtai You'anmen Hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Yong Da — Department of Medical Oncology, Beijing Fengtai You'anmen Hospital
• Study coordinator: Yong Da

Conditions: Solid Tumors, microtransplantation