An Expanded Clinical Study of Triple Therapy for Refracto... | NCT05438342

Status Module

Name	Class
Duke University	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
synchronized hyperthermia autologous progenitor expansion -T (SHAPE-T)	Experimental	Besides NCCN guideline recommended systemic anti-cancer treatment( chemotherapy /anti-PD-1 immmunotherapy/targeted therapy), combined with autoimmune cell therapy combined and noninvasive electromagnetic wave hyperthermia	Biological: Autologous Adoptive immune cells Device: Thermotron RF-8EX Drug: Chemotherapy，checkpoint immunotherapy, targeted therapy
systemic anti-cancer treatment plus Hyperthermia	Active Comparator	BesidesNCCN guideline recommended systemic anti-cancer treatment( chemotherapy /anti-PD-1 immmunotherapy/targeted therapy), combined with noninvasive electromagnetic wave hyperthermia	Device: Thermotron RF-8EX Drug: Chemotherapy，checkpoint immunotherapy, targeted therapy
systemic anti-cancer treatment	Active Comparator	Only apply NCCN guideline recommended systemic anti-cancer treatment ( chemotherapy /anti-PD-1 immmunotherapy/targeted therapy)	Drug: Chemotherapy，checkpoint immunotherapy, targeted therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous Adoptive immune cells	Biological	Immunotherapy Mononuclear cells were collected from 50ml peripheral blood , and cultured adoptive immune cells for 15-20 days. Cells were infused back to the patients in 3 times via intravenous infusion.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival (PFS)	Frome the starting date of the enrollment until the date of the first documented disease progression or the date of the death from any cause,whichever comes first	12 months

Secondary Outcomes

Measure	Description	Time Frame
Overal survival(OS)	Frome the starting date of the enrollment until the date of the death from any cause	24 months
Safty(adverse events)	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients previously diagnosed with solid tumor by histopathology and/or cytology;
Aged 18 and 80, regardless of gender;
ECOG score of general physical condition was 0~2;
The expected survival time is at least 3 months;
Patients with metastatic and recurrent tumors who failed conventional first-line therapy (including those above first-line therapy) and need to change treatment regimens;
According to RECIST standards, at least one measurable objective tumor index (spiral CT detection target lesion 10mm);
WBC 3.0109 /L Hb 90g/L PLT 75.109 /L at baseline upon enrollment;
Normal liver function a) Liver: total bilirubin 2.0 mg/dL(34.2umol/L), 2.5 times the upper limit of AST and ALT, 5 times the upper limit of AST and ALT in patients with liver metastasis b) Kidney: Creatinine 2.5 mg/dL(221umol/L), creatinine clearance rate 60 mL/min;
Understand and sign informed consent and voluntarily participate in clinical research

Exclusion Criteria:

severe active infection and other serious complications;
Patients with a history of autoimmune diseases, including but not limited to multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, excluding vitiligo;
Prednisone can be used in patients with systemic corticosteroid or other immunosuppressive hormone therapy. 0.5 mg/kg/day (maximum cell count group 40 mg/day) or other similar drugs in the same cell count group, inhaled corticosteroids for chronic obstructive pulmonary disease (COPD) or topical administration;
patients who have undergone major organ transplants;
Patients in the active stage of viral hepatitis;
Patients with coagulation dysfunction;
have uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia;
Pregnant or lactating women.
symptomatic brain metastases or mental disorders;
Participated in clinical trials of new drugs within 4 weeks before enrollment;
If the patients are randomly assigned to the hyperthermia treatment group, they need to refer to the exclusion requirements of hyperthermia (the hyperthermia site contains metal or thermal implant, skin allergy to heat, and body position cannot cooperate).
Other factors considered by researchers are not suitable for candidates.

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms