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Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer

ConditionsNSCLCLow Dose RadiotherapyPD-1 InhibitorLeptomeningeal Metastasis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan University

About this trial

This phase I study aims to investigate the safety and efficacy of whole brain low dose radiotherapy (WB-LDRT) combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years old and ≤ 75 years old;

Patients with a definite diagnosis of leptomeningeal metastasis by cerebrospinal fluid cytology, or patients with clinical diagnosis combined with tumor history, neuroimaging, clinical manifestations, cerebrospinal fluid examination, etc.;

Patients with a clear history of lung carcinoma, including histopathological diagnosis or a combination of cytopathology and imaging, and failure of standard treatment;

Efficacy of extracranial lesions SD;

Disqualifiers

Active autoimmune disease or history of autoimmune diseases;

Congenital or acquired immunodeficiency;

Uncontrolled cardiac clinical symptoms or diseases;

Severe infection or severe comorbidities, such as bleeding peptic ulcer, ileus, heart failure, renal failure, or poorly controlled diabetes;

Trial design

Design model

Single group

Treatments tested in this trial

  • Whole Brain Low Dose Radiotherapy

    Radiation

    Whole brain LDRT will be administered at 3 cohorts with increasing dose fractions: Group 1: 4 Gy/2f of one cycle; Group 2: 4 Gy/2f of two cycles (Q3w); Group 3: 4 Gy/2f of three cycles (Q3w). WB-LDRT will be administered in a 4 Gy of 2 fractions over two days, starting from Day 1 in the first cycle (a daily dose of 2 Gy, 4 Gy/2f for one cycle, once per three weeks, at minmum in one cycle and maximum in four cycles in total).

  • Pemetrexed

    Drug

    Pemetrexed, 30 mg, intrathecal injection, once per three weeks, 4 cycles in total

  • Sintilimab

    Drug

    PD-1 inhibitor (Sintilimab, dose as recommended in the instruction manual), intravenous infusion, once per three weeks, 4 cycles in total

  • Chemotherapy

    Drug

    Pemetrexed at a dose of 500 mg/m\^2, intravenous infusion, once per three weeks, 4 cycles in total

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: whole brain LDRT + ICI + intrathecal chemotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Clinical response rate

The RANO proposal for response criteria of leptomeningeal metastasis was used to assess the clinical response in this study.

Time frame
48 months
2

Incidence of treatment-related adverse events

The incidence of treatment-related adverse events were measured for determing tolerability and safety. Adverse events (AEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Events of grade 3-5 are defined as moderate and severe adverse events.

Time frame
48 months

Secondary outcomes

1

Neurological progression-free survival (NPFS)

NPFS was defined as time from the start of treatment until neurological progression or death. The neurological progression was determined based on the RANO proposal evaluation criteria which have been established and published on Neuro Oncol.

Time frame
48 months
2

Overall survival

Survival time was recorded since the date of patient enrollment. All patients were followed up until death or the end of the study.

Time frame
48 months

Other outcomes

Sponsors and contacts

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

Sichuan University

Lead sponsor

Source ClinicalTrials.gov
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