An Expanded Clinical Study of Triple Therapy for Refractory Solid Tumors That Failed First-line Treatment for Recurrence and Metastasis

Shanghai Pudong Hospital

Status: Enrolling

Conditions: Metastatic Cancer; Advanced Cancer

Treatments: Biological: Autologous Adoptive immune cells; Device: Thermotron RF-8EX; Drug: Chemotherapy，checkpoint immunotherapy, targeted therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05438342

2021-IIT-021-E02

Details and patient eligibility

About

The clinical efficacy of chemotherapy /PD-1 monoclonal antibody/targeted therapy, chemotherapy /PD-1 monoclonal antibody/targeted therapy + noninvasive electromagnetic wave hyperthermia and chemotherapy /PD-1 monoclonal antibody/targeted therapy + noninvasive electromagnetic wave hyperthermia + autosomatic immunotherapy in the treatment of refractory refractory solid tumors with first-line treatment failure was compared.

Enrollment: 195 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients previously diagnosed with solid tumor by histopathology and/or cytology;
2. Aged 18 and 80, regardless of gender;
3. ECOG score of general physical condition was 0~2;
4. The expected survival time is at least 3 months;
5. Patients with metastatic and recurrent tumors who failed conventional first-line therapy (including those above first-line therapy) and need to change treatment regimens;
6. According to RECIST standards, at least one measurable objective tumor index (spiral CT detection target lesion 10mm);
7. WBC 3.0109 /L Hb 90g/L PLT 75.109 /L at baseline upon enrollment;
8. 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;
9. Understand and sign informed consent and voluntarily participate in clinical research

Exclusion criteria

1. severe active infection and other serious complications;
2. Patients with a history of autoimmune diseases, including but not limited to multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, excluding vitiligo;
3. 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;
4. patients who have undergone major organ transplants;
5. Patients in the active stage of viral hepatitis;
6. Patients with coagulation dysfunction;
7. have uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia;
8. Pregnant or lactating women.
9. symptomatic brain metastases or mental disorders;
10. Participated in clinical trials of new drugs within 4 weeks before enrollment;
11. 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).
12. Other factors considered by researchers are not suitable for candidates.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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195 participants in 3 patient groups

synchronized hyperthermia autologous progenitor expansion -T (SHAPE-T)

Experimental group

Description:

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

Treatment:

Device: Thermotron RF-8EX

Biological: Autologous Adoptive immune cells

Drug: Chemotherapy，checkpoint immunotherapy, targeted therapy

systemic anti-cancer treatment plus Hyperthermia

Active Comparator group

Description:

BesidesNCCN guideline recommended systemic anti-cancer treatment( chemotherapy /anti-PD-1 immmunotherapy/targeted therapy), combined with noninvasive electromagnetic wave hyperthermia

Treatment:

Device: Thermotron RF-8EX

Drug: Chemotherapy，checkpoint immunotherapy, targeted therapy

systemic anti-cancer treatment

Active Comparator group

Description:

Only apply NCCN guideline recommended systemic anti-cancer treatment ( chemotherapy /anti-PD-1 immmunotherapy/targeted therapy)

Treatment:

Drug: Chemotherapy，checkpoint immunotherapy, targeted therapy