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

NCT05438342 | Unknown

• 1 other identifier: 2021-IIT-021-E02
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Overal survival(OS)

  24 months

• Safty(adverse events)

  12 months

• Patient-Reported Outcome (PRO)

  24 months

Study Arms (3)

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

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.

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

Thermotron RF-8EX DEVICE

Hyperthermia for 40-50 minutes

synchronized hyperthermia autologous progenitor expansion -T (SHAPE-T); systemic anti-cancer treatment plus Hyperthermia

Chemotherapy，checkpoint immunotherapy, targeted therapy DRUG

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

synchronized hyperthermia autologous progenitor expansion -T (SHAPE-T); systemic anti-cancer treatment; systemic anti-cancer treatment plus Hyperthermia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Other factors considered by researchers are not suitable for candidates.

Sponsors & Collaborators

• Shanghai Pudong Hospital: lead
• Duke University: collaborator

Study Sites (1)

Fudan University Pudong Medical Center

Shanghai, Shanghai Municipality, 201399, China

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Ren, MD,PhD

  Fudan University Pudong Medical Center

  STUDY CHAIR

Central Study Contacts

Jun Ren, MD,PhD

CONTACT

021-68035321; jun.ren@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 29, 2022
• Study Start: November 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 31, 2023
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)