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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05438342
• Other study ID #: 2021-IIT-021-E02
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: June 2022
• Source: Shanghai Pudong Hospital
• Contact: Jun Ren, MD,PhD
• Phone: 021-68035321
• Email: jun.ren[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: October 31, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Metastatic Cancer
• Recurrence

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Pudong Medical Center	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Pudong Hospital	Duke University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overal survival(OS)	Frome the starting date of the enrollment until the date of the death from any cause	24 months
Secondary	Safty(adverse events)	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	12 months
Secondary	Patient-Reported Outcome (PRO)	To assess and compare the PRO scores by patients in each group	24 months