Hyperthermia Combined With Immunotherapy in the Treatment of Abdominal and Pelvic Malignancies or Metastases

Capital Medical University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Cancer; Pelvic Cancer; Liver Metastases; Abdominal Cancer; Cancer; Peritoneal Metastases

Treatments: Drug: Anti-PD-1 antibody; Drug: Chemotherapy; Biological: Adoptive cellular Immunotherapy; Device: Thermotron RF-8

Study type: Interventional

Funder types: Other

Identifiers

NCT03757858

RF8-ACT

Details and patient eligibility

About

It is a non-randomized pilot study.The allocation will be determined by patients or their immediate family members who were cooperative with physician's interpretations on the disease progression and updated information of cutting of edge treatment, the financial affordability, availability of treatment plans, possible tolerance or risks etc.The purpose of this study is to investigate the clinical efficacy and toxicity of autologous cellular immunotherapy combined with hyperthermia in abdominal and pelvic malignancies or metastases patients. Furthermore, to characterize response to different regimens,the investigators intent to explore the predictive and prognostic biomarker, as well as the changes in immune repertoire.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Abdominal and pelvic malignancies or metastases
2. Estimated life expectancy > 3 months
3. Age ≥ 18 years old
4. At least one measurable lesion according to the Solid Tumor Evaluation Criteria (RECIST Version 1.1)
5. Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR <1.5 (unless patient is receiving warfarin in which case PT-INR must be <3), PTT <1.5X ULN
6. Adequate renal and hepatic function, with serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.

Exclusion criteria

1. Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune related thyroid disease and vitiligo are permitted.
2. Patients with serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment.
3. Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded.
4. Concurrent (or within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, controlled superficial bladder cancer, or other carcinoma in situ that has been treated.
5. Presence of an active acute or chronic infection including: a urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
6. Patients on chronic steroid therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies or for acute treatment (<5 days) of intercurrent medical condition such as a gout flare) prior to enrollment.
7. Pregnant and nursing women should be excluded from the protocol since this research may have unknown and harmful effects on an unborn child or on young children. If the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of 4 months following the last vaccination therapy. It is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study.
8. Patients with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded.
9. There are metal stents or metal fixtures in the body

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

HT+ACT

Experimental group

Treatment:

Biological: Adoptive cellular Immunotherapy

Device: Thermotron RF-8

HT+ACT+PD-1

Experimental group

Treatment:

Drug: Anti-PD-1 antibody

Biological: Adoptive cellular Immunotherapy

Device: Thermotron RF-8

HT+ACT+CT

Experimental group

Treatment:

Drug: Chemotherapy

Biological: Adoptive cellular Immunotherapy

Device: Thermotron RF-8

HT+CT

Active Comparator group

Treatment:

Drug: Chemotherapy

Device: Thermotron RF-8