Health TrialsbyHealthPanel

Interventional Software for Multi-immunotherapy of Solid Tumors

ConditionsLung CancerLiver CancerSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Guangzhou Medical University

About this trial

This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by intra-tumor (IT) injection of multiple drugs including CTLA4, PD1, and/or PDL1 antibodies combined with drugs-eluting beads loaded with IL2, chemodrug, anti-angiogenesis drug, et. al that will be recommended by an AI-based medical software named IRSW-MIM developed by a cooperating company.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cytohistological confirmation is required for diagnosis of cancer.

Signed informed consent before recruiting.

Age above 18 years with estimated survival over 3 months.

Child-Pugh class A or B/Child score > 7; ECOG score < 2

Disqualifiers

Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;

Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;

Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;

Patients accompanied with other tumors or past medical history of malignancy;

Trial design

Design model

Single group

Treatments tested in this trial

  • IRSW-MIM

    Device

    IRSW-MIM collects patient's data and outputs a therapeutical strategy for treating advanced solid tumors.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: IRSW-MIMExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of the reccommended treatment generated by the medical device

Safety will be assessed by recording all types of advise effects upon and after the treatment.

Time frame
5 years
2

Progression-free survival

Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.

Time frame
5 years
3

Disease control rate

Disease control rate will be defined as objective response rate + steady disease rate.

Time frame
5 years
4

Duration of remission (DOR)

DOR will be defined as the duration of the cancer remission

Time frame
5 years

Secondary outcomes

1

Overall survival

Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital of Guangzhou Medical University

Lead sponsor

Immuno (Guangzhou) Biomedicine S&T Ltd

Collaborator

Source ClinicalTrials.gov
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