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

Last updated: February 5, 2024
Sponsor: Capital Medical University
Overall Status: Completed

Phase

1/2

Condition

Metastatic Cancer

Liver Metastases

Peritoneal Cancer

Treatment

Anti-PD-1 antibody

Thermotron RF-8

Adoptive cellular Immunotherapy

Clinical Study ID

NCT03757858
RF8-ACT
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 isacceptable 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), ALTand AST ≤ 2.5 x upper limit of normal.
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.

Exclusion

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 vitiligoare 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 PrincipalInvestigator as unwarranted high risk for investigational drug treatment.
  3. Patients with a medical or psychological impediment to probable compliance with theprotocol should be excluded.
  4. Concurrent (or within the last 5 years) second malignancy other than non melanoma skincancer, cervical carcinoma in situ, controlled superficial bladder cancer, or othercarcinoma 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 areexcluded based on immuno-suppression, which may render them unable to respond to thevaccine; patients with chronic hepatitis are excluded because of concern thathepatitis could be exacerbated by the injections.
  6. Patients on chronic steroid therapy (or other immuno-suppressives, such asazathioprine or cyclosporin A) are excluded on the basis of potential immunesuppression. Patients must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies orfor 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 researchmay have unknown and harmful effects on an unborn child or on young children. If thepatient is sexually active, the patient must agree to use a medically acceptable formof birth control while receiving treatment and for a period of 4 months following thelast vaccination therapy. It is not known whether the treatment used in this studycould affect the sperm and could potentially harm a child that may be fathered whileon this study.
  8. Patients with acute or chronic skin disorders that will interfere with injection intothe skin of the extremities or subsequent assessment of potential skin reactions willbe excluded.
  9. There are metal stents or metal fixtures in the body

Study Design

Total Participants: 40
Treatment Group(s): 4
Primary Treatment: Anti-PD-1 antibody
Phase: 1/2
Study Start date:
March 01, 2018
Estimated Completion Date:
June 01, 2023

Connect with a study center

  • Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

    Beijing, Beijing 100038
    China

    Site Not Available

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