Program Status
RecruitingPhase
Not ApplicablePrior Immunotherapy Allowed
YesCRC-directed Trial
NoDrugs
Chemotherapy,checkpoint immunotherapy, targeted therapyTags
MSI-H/ MMRd, MSS/ MMRpComments
Novel treament, for solid tumors (which includes CRC) in addition to standard of care.
For patients with metastatic and recurrent tumors for whom conventional first-line therapy failed and need to change treatment regimen (it is also for patients above first-line therapy).
Patients are assigned to one of these 3 arms of the trial:
1. Patients receive “synchronized hyperthermia autologous progenitor expansion -T (SHAPE-T), plus standard of care”.
This is: noninvasive electromagnetic wave hyperthermia (Thermotron RF-8EX), plus autosomatic immunotherapy (autologous adoptive immune cells), in addition to the standard of care, recommended systemic anti-cancer treatment for their type of cancer.
2. Patients receive noninvasive electromagnetic wave hyperthermia (Thermotron RF-8EX) in addition to the standard of care, recommended systemic anti-cancer treatment for their type of cancer.3. Patients receive standard of care, recommended systemic anti-cancer treatment for their type of cancer.
Only location for the trial is Shangai; Duke University (U.S.) is collaborator in this research; Dr Jun Ren is PI.
Location | Location Status |
---|---|
China | |
Fudan University Pudong Medical Center Shanghai, Shanghai 201399 |
Recruiting |
Contacts
Inclusion 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
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.