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

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cancer; Advanced Cancer
• Intervention / Treatment: Biological: Autologous Adoptive immune cells; Device: Thermotron RF-8EX; Drug: Chemotherapy，checkpoint immunotherapy, targeted therapy

• Study Type: Interventional
• Enrollment (Anticipated): 195
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201399
      • Recruiting
      • Fudan University Pudong Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: 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.; Device: Thermotron RF-8EX; Hyperthermia for 40-50 minutes; Drug: Chemotherapy，checkpoint immunotherapy, targeted therapy; The doctor chooses the appropriate systemic treatment for the patient based on NCCN guidelines
Active Comparator: 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	Device: Thermotron RF-8EX; Hyperthermia for 40-50 minutes; Drug: Chemotherapy，checkpoint immunotherapy, targeted therapy; The doctor chooses the appropriate systemic treatment for the patient based on NCCN guidelines
Active Comparator: systemic anti-cancer treatment; Only apply NCCN guideline recommended systemic anti-cancer treatment ( chemotherapy /anti-PD-1 immmunotherapy/targeted therapy)	Drug: Chemotherapy，checkpoint immunotherapy, targeted therapy; The doctor chooses the appropriate systemic treatment for the patient based on NCCN guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	12 months
Patient-Reported Outcome (PRO)	To assess and compare the PRO scores by patients in each group	24 months

Collaborators and Investigators

• Sponsor: Shanghai Pudong Hospital
• Collaborators: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 2021-IIT-021-E02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No