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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Principal investigator: You Lu, MD — West China Hospital
• Study coordinator: Ren Luo, MD
• Email: luorenbu@163.com
• Phone: 18349337131

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating BGB-26808 alone or with Tislelizumab for advanced solid tumors

  This study is testing a new treatment called BGB-26808, both by itself and with another drug called Tislelizumab, to see how well it works and what the best dose is for people with advanced solid tumors.

  Recruiting at 21 sites Phase 1 BeOne Medicines · Duarte, California and 27 other locations · NCT05981703

• Tislelizumab with Tofacitinib and Docetaxel for NSCLC After First-Line Immunotherapy

  This study tests whether adding tofacitinib to tislelizumab and docetaxel helps people with locally advanced or metastatic NSCLC who did not respond to first-line immunotherapy.

  Recruiting Phase 2 Anhui Provincial Hospital · Hefei, Anhui · NCT07925866

• SYS6010 plus Enlonstobart for recurrent or metastatic nasopharyngeal cancer in patients who have not had prior systemic therapy

  This trial tests whether SYS6010 with Enlonstobart works better than Tislelizumab with gemcitabine and cisplatin for people whose recurrent or metastatic nasopharyngeal cancer has not yet received systemic treatment.

  Recruiting Phase 3 CSPC Megalith Biopharmaceutical Co.,Ltd. · Guangzhou, Guangzhou · NCT07925021

• Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX

  This study tests whether adding fruquintinib to short-course radiotherapy plus tislelizumab and CAPOX before surgery helps people with locally advanced low rectal cancer achieve a better tumor response.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07888309

• SumMET: Targeted radioligand therapy for c-MET–positive solid tumors

  This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.

  Recruiting at 2 sites Phase 1/2 Full-Life Technologies UK Limited · Minneapolis, Minnesota and 1 other locations · NCT07873450

• SHR-4595 Injection in Advanced Solid Tumors: Safety, Tolerability, and Dosing in Phase 1

  This early-phase trial tests SHR-4595 injections to see if they are safe and tolerable for adults with advanced solid tumors who have exhausted standard treatments.

  Recruiting at 2 sites Phase 1 Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Shenyang, Liaoning and 1 other locations · NCT07830199

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.