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Trial Title:
Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors
NCT ID:
NCT06349837
Condition:
Solid Tumor
Conditions: Official terms:
Tislelizumab
Immune Checkpoint Inhibitors
Conditions: Keywords:
Low Dose Radiotherapy
Stereotactic Ablative Radiotherapy
Tislelizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Patients will receive treatment with Tislelizumab (200 mg, iv, d1), every 3 weeks for a
maximum of 48 months.
Arm group label:
LDRT+SBRT + Tislelizumab
Other name:
PD-1 inhibitor
Intervention type:
Radiation
Intervention name:
Low Dose Radiotherapy
Description:
LDRT (d1-d3): 6Gy/3f with conventional external beam radiation.
Arm group label:
LDRT+SBRT + Tislelizumab
Other name:
LDRT
Intervention type:
Radiation
Intervention name:
Stereotactic Ablative Radiotherapy
Description:
Partial SBRT at dose escalation levels: 24Gy/3f, 30Gy/3f, 45Gy/3f.
Arm group label:
LDRT+SBRT + Tislelizumab
Other name:
SBRT
Summary:
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.
Detailed description:
This is 3+3 escalation phase I study which will be conducted in West China Hospital.
3 patients per cohort (a total of 9 patients) will be enrolled to observe the
dose-limiting toxicity (DLT) and recommended dose for expansion (RDE) for lung LDRT and
partial SBRT.
All eligible patients will receive LDRT + partial SBRT and Tislelizumab at different dose
levels (decried as below). Tislelizumab will be given at 200mg as recommended in the
instruction manual every 3 weeks until disease progression, unacceptable toxicities, the
patient withdraws informed consent, or Tislelizumab reaches a maximum of up to 24 months.
Patients in the dose escalation will receive LDRT + partial SBRT at 3 cohorts with
increasing dose levels: 6 Gy (2 Gy/f) + 24 Gy (8 Gy/f); 6 Gy (2 Gy/f) + 30 Gy (10 Gy/f);
6 Gy (2 Gy/f) + 45 Gy (15 Gy/f).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Be willing and able to provide written informed consent/assent for the trial.
2. Be ≥18 years of age on day of signing informed consent.
3. Patients with histologically or cytologically confirmed stage IV NSCLC.
4. Be willing to undergo repeat biopsy of tumor lesions according to the study
protocol.
5. Patients who have failed the standard therapy, or who are unsuitable for standard
treatment, or refuse chemotherapy.
6. At least one measurable lesion according to RECIST 1.1. A lesion that has previously
received radiotherapy can be considered a target lesion only if this lesion is
clearly progressed after radiotherapy.
7. The target lesions (irradiated lesions) are > 5cm in in diameter
8. ECOG 0-2.
9. Life expectancy of > 3 months.
10. Subjects should agree to use an adequate method of contraception.
Exclusion Criteria:
1. Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis and/or spinal cord compression, etc.
2. With oncologic emergencies that require immediate treatment
3. EGFR/ALK/ROS-1 mutation or mutation status unknown.
4. Has evidence of interstitial lung disease or active and/or non-infectious
pneumonitis (drug-induced pneumonia, radiation-induced pneumonia, etc.) requiring
steroid therapy.
5. History of pulmonary fibrosis, pulmonary hypertension, severe irreversible airway
obstruction disease
6. Patients with peripheral neuropathy.
7. Significant heart disease or impairment of cardiac function
8. Fluid accumulating in the third space, such as pericardial effusion, pleural
effusion and peritoneal effusion that remains uncontrolled by aspiration or other
treatment
9. Known allergy to drugs or excipients, known severe allergic reaction to any of the
PD-1 monoclonal antibodies
10. Known allogeneic organ transplantation (except corneal transplantation) or
allogeneic hematopoietic stem cell transplantation.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Ren Luo, MD
Phone:
18349337131
Email:
luorenbu@163.com
Start date:
April 18, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06349837
