Health TrialsbyHealthPanel

Checkpoint Inhibitor Combinations Therapy as First Line for Inoperable Lung Cancer Via IT

ConditionsLung CancerInoperable Disease
Trial statusRecruiting
Trial phasePhase 2
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 inoperable lung cancer by infusion of CTLA4, PD1 and PDL1 antibodies combination with chemodrug or/and bevacizumab through intra-tumor (IT).

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

Parallel

Treatments tested in this trial

  • ipilimumab+pembrolizumab or ipilimumab+durvalumab, idarubicin, bevacizumab

    Drug

    This study has 3 subgroups: Arm 1. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab is administrated with a total dose of 1-2mg/kg via intra-tumor fine needle injection in 10 min, every 3 weeks. Arm 2. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin is administrated via intra-tumor fine needle injection in 15 min, every 3 weeks. Arm 3. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin plus bevacizumab is administrated via intra-tumor fine needle injection in 20 min, every 3 weeks.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: IT injection of double ICIExperimental treatment 1 intervention
Group B: IT injection of double ICI and chemodrugExperimental treatment 1 intervention
Group C: IT injection of double ICI and chemodrug plus bevacizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of IT delivery of drugs combination treatment

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

Source ClinicalTrials.gov
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