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

Primary Purpose

Advanced Cancer, Metastatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Autologous Adoptive immune cells
Thermotron RF-8EX
Chemotherapy，checkpoint immunotherapy, targeted therapy
Sponsored by
Shanghai Pudong Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fudan University Pudong Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

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

systemic anti-cancer treatment plus Hyperthermia

systemic anti-cancer treatment

Arm 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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overal survival(OS)
Frome the starting date of the enrollment until the date of the death from any cause
Safty(adverse events)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Patient-Reported Outcome (PRO)
To assess and compare the PRO scores by patients in each group

Full Information

First Posted
June 16, 2022
Last Updated
June 24, 2022
Sponsor
Shanghai Pudong Hospital
Collaborators
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05438342
Brief Title
An Expanded Clinical Study of Triple Therapy for Refractory Solid Tumors That Failed First-line Treatment for Recurrence and Metastasis
Official Title
An Expanded Clinical Study of Triple Therapy for Refractory Solid Tumors That Failed First-line Treatment for Recurrence and Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Pudong Hospital
Collaborators
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Metastatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
195 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
synchronized hyperthermia autologous progenitor expansion -T (SHAPE-T)
Arm Type
Experimental
Arm 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
Arm Title
systemic anti-cancer treatment plus Hyperthermia
Arm Type
Active Comparator
Arm Description
BesidesNCCN guideline recommended systemic anti-cancer treatment( chemotherapy /anti-PD-1 immmunotherapy/targeted therapy), combined with noninvasive electromagnetic wave hyperthermia
Arm Title
systemic anti-cancer treatment
Arm Type
Active Comparator
Arm Description
Only apply NCCN guideline recommended systemic anti-cancer treatment ( chemotherapy /anti-PD-1 immmunotherapy/targeted therapy)
Intervention Type
Biological
Intervention Name(s)
Autologous Adoptive immune cells
Intervention Description
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
Device
Intervention Name(s)
Thermotron RF-8EX
Intervention Description
Hyperthermia for 40-50 minutes
Intervention Type
Drug
Intervention Name(s)
Chemotherapy，checkpoint immunotherapy, targeted therapy
Intervention Description
The doctor chooses the appropriate systemic treatment for the patient based on NCCN guidelines
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overal survival(OS)
Description
Frome the starting date of the enrollment until the date of the death from any cause
Time Frame
24 months
Title
Safty(adverse events)
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
12 months
Title
Patient-Reported Outcome (PRO)
Description
To assess and compare the PRO scores by patients in each group
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Ren, MD,PhD
Phone
021-68035321
Email
jun.ren@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Ren, MD,PhD
Organizational Affiliation
Fudan University Pudong Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fudan University Pudong Medical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201399
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ren, MD,PhD
Phone
021-68035322
Email
jun.ren@duke.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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