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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 1, 2018

Primary Completion Date

December 31, 2022

Study Completion Date

June 1, 2023

Conditions
CancerAbdominal CancerPelvic CancerMetastatic CancerPeritoneal MetastasesLiver Metastases
Interventions
DEVICE

Thermotron RF-8

Hyperthermia for 40 minutes, with maximum temperature setted on 42℃ ± 0.5℃ as upper limit, twice a week for a total of 10 times.

BIOLOGICAL

Adoptive cellular Immunotherapy

Mononuclear cells were collected from 50ml peripheral blood , and cultured cytokine-induced killer cells for 15-20 days. Cells were infused back to the patients in 3 times via intravenous infusion .Patients will received at least 2 cycles of CIK Immunotherapy . If the evaluation of the treatment is complete response, partial response or stable disease, additional cycles were eligible.

DRUG

Anti-PD-1 antibody

Patients will receive pembrolizumab 100mg every three weeks and assess the clinical outcome every 2 dosage of anti-PD-1 antibody treatment.

DRUG

Chemotherapy

Patients will receive standard chemotherapy until disease progression, unacceptable toxicity or patient refusal.

Trial Locations (1)

100038

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital, Beijing

All Listed Sponsors
lead

Capital Medical University

OTHER

NCT03757858 - Hyperthermia Combined With Immunotherapy in the Treatment of Abdominal and Pelvic Malignancies or Metastases | Biotech Hunter | Biotech Hunter