New combo therapy for bulky tumors enters human testing
NCT ID NCT06349837
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a combination of low dose radiotherapy, focused radiation (SBRT), and the immunotherapy drug tislelizumab in people with large solid tumors that have not responded to standard treatments. The study aims to see if this approach is safe and tolerable. About 24 participants will be enrolled, and the main focus is on side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tislelizumab (a drug that helps the immune system fight cancer), low dose radiotherapy, and stereotactic ablative radiotherapy (focused radiation)
- What this could lead to
- If successful, this could point toward a new treatment option for people with large tumors that have not responded to standard therapy.
- What could go wrong
- This is a very early, small Phase 1 trial with only 24 participants, so results may not apply to everyone. The main goal is safety, not effectiveness, and there are risks from radiation and immune-related side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West China Hospital, Sichuan University
RECRUITINGChengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test
- New injectable drug tested for safety in Hard-to-Treat solid tumors
- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors
- Can a new drug shield kidneys from chemotherapy damage?
- Mining Responders' tumors for clues to a universal cancer therapy
- Proton boost radiotherapy aims to hit large tumors harder while sparing healthy tissue