Immunotherapy cocktail takes on tough throat cancer
NCT ID NCT07392320
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding an immunotherapy drug (penpulimab) to standard chemotherapy and radiation, followed by maintenance immunotherapy, works better than the usual maintenance drug capecitabine for people with high-risk nasopharyngeal cancer. About 142 participants with advanced disease will be randomly assigned to one of two treatment groups. The goal is to see which approach better prevents the cancer from returning or spreading.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Penpulimab (immunotherapy drug) combined with chemotherapy (docetaxel, cisplatin) and radiation, compared to capecitabine (chemotherapy pill)
- What this could lead to
- If this works, it could offer a more effective treatment plan for high-risk nasopharyngeal cancer, potentially improving survival without the cancer coming back.
- What could go wrong
- This is a small, early-phase (Phase 2) trial, so results may not apply to everyone. Immunotherapy can cause immune-related side effects, and the added benefit over standard care is not yet proven.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 142 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2026
- Expected to finish
-
Feb 2033
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 70 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.
Inclusion Criteria: * Voluntary participation and written informed consent must be signed. * Age between 18 and 70 years, male or non-pregnant female. * Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III). * Stage III disease (AJCC 9th edition staging) or pre-treatment plasma Epstein-Barr virus DNA (EBV DNA) ≥ 1500 copies/ml. * Efficacy after 3 cycles of induction immunochemotherapy assessed as complete response (CR) or partial response (PR) by nasopharyngoscopy and contrast-enhanced MRI of the nasopharynx and neck. * ECOG performance status score of 0 or 1. * Adequate hematological function: Hemoglobin (HGB)≥90g/L, White Blood Cell (WBC) ≥ 4.010\^9/L, and Platele (PLT) ≥10010\^9/L. * Adequate hepatic function: ALT and AST≤2.5Upper Limit of Normal (ULN), total bilirubin ≤2.0ULN, and serum albumin≥30g/L. * Adequate renal function: Serum creatinine ≤ 1.5\*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula). * International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 \*ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening). Exclusion Criteria: * Patients with recurrent or distant metastatic nasopharyngeal carcinoma. * Pathological diagnosis of keratinizing squamous cell carcinoma (WHO Type I). * Patients who have previously received radiotherapy or systemic chemotherapy. * Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception. * HIV positive. * History of other malignancies (except for cured basal cell carcinoma or cervical carcinoma in situ). * Patients who have previously received immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors). * Patients with immunodeficiency diseases or a history of organ transplantation. * History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. * Patients who have received high-dose glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressive therapy within 4 weeks. * Patients with significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function. * Patients with severe, uncontrolled medical conditions or infections. * Concurrent use of other investigational drugs or participation in another clinical trial. * Refusal or inability to sign the informed consent form for trial participation. * Patients with other contraindications to the treatment. * Patients with personality or psychiatric disorders, or those lacking or with limited legal capacity. * Patients who are hepatitis B surface antigen (HBsAg) positive with peripheral blood hepatitis B virus DNA (HBV DNA) ≥ 1000 copies/ml. Patients who are HBsAg positive but have HBV DNA \< 1000 copies/ml are eligible if the investigator determines that their chronic hepatitis B is stable and does not pose an increased risk. * Patients with a positive HCV antibody test result, unless the polymerase chain reaction (PCR) test for HCV RNA is negative.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Locally advanced high-risk nasopharyngeal 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
RECRUITINGGuangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a common antiseptic spray stop radiation burns in cancer patients?
- Second radiation may boost survival in returning throat cancer
- Low-Dose radiation plus immunotherapy shows promise for Tough-to-Treat nasopharyngeal cancer
- New combo therapy targets stubborn nasopharyngeal cancer in phase 3 trial
- Could delaying radiation be just as good for advanced nasopharyngeal cancer?
- New hope for Hard-to-Treat cancers: enhertu studied in 20+ tumor types