Microtransplantation for Advanced and Relapsed Solid Tumors

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumors

Treatments: Biological: microtransplantation, HLA-mismatched donor peripheral stem cell infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04937842

MST-ST-01

Details and patient eligibility

About

In this study, we will apply micro transplantation to the field of solid tumors to study the efficacy and safety of radiotherapy and chemotherapy combined with micro transplantation in the treatment of advanced / relapsed solid tumors.

Full description

The eligible patients are assigned to the experimental group (microtransplantation group, MST group) or the control group (CT) according to the availability of suitable donors. In MST group, peripheral blood hematopoietic stem cells from HLA mismatched donors mobilized with granulocyte colony stimulating factor are infused after conventional chemotherapy and/or radiotherapy ; The CT group only received conventional chemotherapy and/or radiotherapy. According to the patient's past medical history, current tumor assessment results, and the latest cancer treatment guidelines, the individualized chemotherapy and / or radiotherapy plan for the patient is formulated after discussion by more than 3 oncologists. After each course of treatment, the efficacy and safety are evaluated. For the patients who are evaluated to be effective or stable (SD) after the first treatment, the second treatment of the same scheme will be given. Those who reach the disease control level will continue to be treated for 4 courses, with an interval of 28 days. The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study. Patients are allowed to receive any treatment, including symptomatic support treatment, after the end of treatment or withdrawal from the study.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

MST

Experimental group

Description:

standard chemotherapy with microtransplantation

Treatment:

Biological: microtransplantation, HLA-mismatched donor peripheral stem cell infusion

CT

No Intervention group

Description:

standard chemotherapy only, without microtransplantation