Evaluating a new treatment combining low dose radiotherapy and immunotherapy for bulky tumors

Safety and Tolerability of Low Dose Radiotherapy Plus Concurrent Partial Stereotactic Ablative Radiotherapy (Eclipse-RT) and Tislelizumab in Patients With Bulky Tumors

This study is testing a new treatment that combines low dose radiation and an immunotherapy drug to see if it can help people with large tumors that haven't improved with standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan University (Academic / other)
• Drugs / interventions: chemotherapy, radiation, Tislelizumab
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06349837 on ClinicalTrials.gov

What this trial studies

This phase I clinical trial aims to assess the safety and tolerability of low dose radiotherapy (LDRT) combined with partial Stereotactic Ablative Radiotherapy (SBRT) and the immunotherapy drug Tislelizumab in patients with bulky tumors who have not responded to standard treatments. The study will enroll at least 9 participants, using a 3+3 dose escalation design to determine the maximum tolerated doses and observe any dose-limiting toxicities. Participants will receive LDRT and SBRT at varying doses alongside Tislelizumab, administered every three weeks until disease progression or unacceptable side effects occur.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stage IV non-small cell lung cancer (NSCLC) who have failed standard therapies.

Not a fit: Patients with active central nervous system metastases or those who are not suitable for repeat biopsies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced bulky tumors who have exhausted standard treatment options.

How similar studies have performed: While this specific combination of therapies is novel, similar approaches using immunotherapy and radiotherapy have shown promise in other studies.

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 solid tumours.
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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: You Lu, MD — West China Hospital
• Study coordinator: Ren Luo, MD

Conditions Solid Tumor; Low Dose Radiotherapy; Stereotactic Ablative Radiotherapy; Tislelizumab