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Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors

ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan University

About this trial

This is a 3+3 dose escalation phase I study which aims to evaluate the safety and tolerability of low dose radiotherapy (LDRT) plus concurrent partial Stereotactic Ablative Radiotherapy (SBRT) and Tislelizumab in Patients with bulky tumors who have failed standard therapy. At least 9 participants will be enrolled in this study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be willing and able to provide written informed consent/assent for the trial.

Be ≥18 years of age on day of signing informed consent.

Patients with histologically or cytologically confirmed stage IV solid tumours.

Be willing to undergo repeat biopsy of tumor lesions according to the study protocol.

Disqualifiers

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis and/or spinal cord compression, etc.

With oncologic emergencies that require immediate treatment

EGFR/ALK/ROS-1 mutation or mutation status unknown.

Has evidence of interstitial lung disease or active and/or non-infectious pneumonitis (drug-induced pneumonia, radiation-induced pneumonia, etc.) requiring steroid therapy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

    Patients will receive treatment with Tislelizumab (200 mg, iv, d1), every 3 weeks for a maximum of 48 months.

  • Low Dose Radiotherapy

    Radiation

    LDRT (d1-d3): 6Gy/3f with conventional external beam radiation.

  • Stereotactic Ablative Radiotherapy

    Radiation

    Partial SBRT at dose escalation levels: 24Gy/3f, 30Gy/3f, 45Gy/3f.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: LDRT+SBRT + TislelizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicities

Time frame
24 months

Secondary outcomes

1

Objective Response Rate (ORR)

The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.

Time frame
up to 24 months after the enrollment
2

Progression Free Survival (PFS)

Investigator assessed PFS according to RECIST v1.1. Progression free survival is defined as time of enrollment to first evidence of progressive disease.

Time frame
up to 24 months after the enrollment
3

Overall Survival (OS)

OS is defined as the difference (in months) between the date of study enrollment to the date death due to any cause

Time frame
up to 24 months after the enrollment

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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