Efficacy and Safety of Microtransplantation for Advanced and Relapsed Solid Tumors

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Status and phase

Not yet enrolling

Phase 1

Conditions

Advanced and Relapsed Solid Tumors

Treatments

Biological: MST

Study type

Interventional

Funder types

Other

Identifiers

NCT07356856

MST-ST-02

Details and patient eligibility

About

In this study, microtransplantation (MST) will be administrated to patients diagnosed with advanced / relapsed solid tumors to assess the therapeutic efficacy and safety of conventional chemotherapy in combination with MST for the treatment of advanced/relapsed solid tumors.

Full description

In this study, the eligible patients will receive MST treatment following conventional chemotherapy, MST is the infusion of G-PBMCs after chemotherapy. G-PBMCs are peripheral blood mononuclear cells from HLA mismatched unrelated donors mobilized by granulocyte colony-stimulating factor (G-CSF).

Based on the patient's medical history, current tumor assessment results, and the latest cancer treatment guidelines, an individualized chemotherapy plan for the patient is formulated through discussions among more than three oncologists. After each course of treatment, all relevant indicators, including efficacy and safety measures are evaluated.

Patients will receive all treatment for four courses, with an interval of 21 to 28 days. After completing all the treatment courses, the patient will enter the evaluation stage. Patients who have entered the evaluation stage are permitted to receive any treatments, including symptomatic support treatment, after the completion of treatment or withdrawal from the study.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients are 18 to 90 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 ≥ 40, ECoG physical status ≤ 3;
There are measurable lesions;

Exclusion criteria

The researchers considered patients who were not suitable to participate in this experiment；
Patients with mental disorders；
Patients who refuse to cooperate with the treatment；