Triple threat: radiation, chemo, and immunotherapy before surgery shows promise for oral cancer
NCT ID NCT07402538
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests whether giving a short course of targeted radiation (SBRT) followed by chemotherapy and immunotherapy before surgery can improve outcomes for people with advanced oral or HPV-negative throat cancer. About 184 participants will be randomly assigned to receive either this new combination or standard treatment. The main goal is to see if the combination increases the chance of being cancer-free two years after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stereotactic body radiotherapy (SBRT) plus tislelizumab, docetaxel, and cisplatin
- What this could lead to
- If successful, this approach could improve long-term survival and reduce recurrence for patients with advanced oral and throat cancers.
- What could go wrong
- This is an early-stage Phase 3 trial not yet recruiting. The combination of radiation, chemo, and immunotherapy may cause significant side effects, and results may not apply to all patients.
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
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 184 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Feb 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2030
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
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.
The inclusion criteria for this study are as follows: * Histologically and/or cytologically confirmed treatment-naïve oral squamous cell carcinoma or HPV-negative oropharyngeal squamous cell carcinoma. * Clinical stage III -Ⅳa (8th edition of AJCC). * Age: 18 to 75 years old. * According to the Eastern Cooperative Oncology Group (ECOG) criteria (with a performance status score of 0 or 1). * Good organ function. * Expected survival time: ≥ 3 months. * The patient has signed the informed consent form and is willing and able to comply with the study's scheduled visits, treatment plans, laboratory tests, and other research procedures. * Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrolment and must agree to use highly effective contraceptive measures during the study period and for at least 60 days after the last dose (including chemotherapeutic drugs and Tislelizumab). * If the female partner of a male subject is still of childbearing potential, the male subject must agree to use highly effective contraceptive measures during the study period and for at least 60 days after the last dose. Exclusion Criteria: * Patients with concurrent other malignant tumors * Patients with known or suspected autoimmune diseases, including dementia and epilepsy. * Patients with severe mental disorders at the same time * Patients with necrotic lesions who are assessed by the investigator as having a risk of massive hemorrhage * Patients with severe heart disease or pulmonary dysfunction, and those with cardiac or pulmonary function grade ≤ 3 (grade 3 inclusive) * Patients with laboratory test results that do not meet the relevant criteria within 7 days prior to enrollment * Received systemic or local glucocorticoid therapy within 4 weeks prior to enrollment * Patients with comorbidities requiring long-term treatment with immunosuppressive drugs, or requiring systemic or local administration of corticosteroids at immunosuppressive doses. * Patients with active tuberculosis (TB), who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening. * A history of prior use of anti-Tislelizumab, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulation or checkpoint pathways). * Subjects with any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism); subjects with vitiligo or those whose childhood asthma has been completely relieved and who do not require any intervention in adulthood are eligible for enrollment; those with asthma requiring medical intervention with bronchodilators are not eligible for enrollment. * HIV-positive subjects * Positive for HBsAg with concurrent positive HBV DNA copy number (quantitative test ≥ 1000 cps/ml); positive for chronic hepatitis C on blood screening (HCV antibody positive) * Received any anti-infective vaccines (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment * Pregnant women with positive pregnancy test results among females of childbearing potential and lactating women.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HPV-negative oropharyngeal squamous cell carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Lighting up oral cancer: dye may help surgeons see tumor edges
- Can a glowing light reveal hidden mouth lesions?
- Can a laser scan catch mouth cancer before it spreads?
- Can a prosthetic device restore quality of life after facial defects?
- Can a more intense radiation schedule outperform Chemo-Radiation for head and neck cancer?
- Can a Two-Drug punch shrink oral tumors before surgery?