Microtransplantation for Advanced and Relapsed Solid Tumors

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04937842
• Other study ID #: MST-ST-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 1, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2021
• Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Contact: Yong Da
• Phone: 8613466665939
• Email: 15811031508[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2025
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Biological:
• microtransplantation, HLA-mismatched donor peripheral stem cell infusion
infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)

Locations

Country	Name	City	State
China	Beijing Fengtai You'anmen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-Emergent Adverse Events	Treatment related mortality	1 month
Primary	time of hematopoietic recovery	Absolute neutrophil count >500/mcL; Platelets =20,000/mcL	1 month
Secondary	overall response rate	(markedly effective + effective) / number of patients × 100%	1year