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

NCT ID: NCT05438342

Last Updated: 2022-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-10-31

Brief Summary

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.

Conditions

Advanced Cancer; Metastatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: EXPERIMENTAL

Autologous Adoptive immune cells

Intervention Type: 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.

Thermotron RF-8EX

Intervention Type: DEVICE

Hyperthermia for 40-50 minutes

Chemotherapy，checkpoint immunotherapy, targeted therapy

Intervention Type: DRUG

The doctor chooses the appropriate systemic treatment for the patient based on NCCN guidelines

systemic anti-cancer treatment plus Hyperthermia

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

Group Type: ACTIVE_COMPARATOR

Thermotron RF-8EX

Intervention Type: DEVICE

Hyperthermia for 40-50 minutes

Chemotherapy，checkpoint immunotherapy, targeted therapy

Intervention Type: DRUG

The doctor chooses the appropriate systemic treatment for the patient based on NCCN guidelines

systemic anti-cancer treatment

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

Group Type: ACTIVE_COMPARATOR

Chemotherapy，checkpoint immunotherapy, targeted therapy

Intervention Type: DRUG

The doctor chooses the appropriate systemic treatment for the patient based on NCCN guidelines

Interventions

Autologous Adoptive immune cells

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.

Intervention Type: BIOLOGICAL

Thermotron RF-8EX

Hyperthermia for 40-50 minutes

Intervention Type: DEVICE

Chemotherapy，checkpoint immunotherapy, targeted therapy

The doctor chooses the appropriate systemic treatment for the patient based on NCCN guidelines

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Shanghai Pudong Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Ren, MD,PhD

Role: STUDY_CHAIR

Fudan University Pudong Medical Center

Locations

Fudan University Pudong Medical Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Ren, MD,PhD

Role: CONTACT

jun.ren@duke.edu

021-68035321

Facility Contacts

Jun Ren, MD,PhD

Role: primary

jun.ren@duke.edu

021-68035322

Other Identifiers

2021-IIT-021-E02

Identifier Type: -

Identifier Source: org_study_id