Can a blood test and MRI tailor cancer therapy to each patient?
NCT ID NCT07762976
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This trial tests whether giving extra chemotherapy or a combination of chemotherapy and immunotherapy after standard treatment can improve outcomes for people with nasopharyngeal carcinoma. The choice of treatment is based on each patient's risk level, determined by changes in a blood marker (EBV-DNA) and MRI scans. The goal is to see if this personalized approach can reduce the chance of the cancer coming back 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
- Adjuvant therapy with capecitabine alone or combined with tislelizumab, guided by risk assessment
- What this could lead to
- If successful, this approach could personalize adjuvant treatment for nasopharyngeal carcinoma, potentially improving survival and reducing unnecessary side effects.
- What could go wrong
- This is a phase II trial, so results are preliminary. The benefit may be modest, and adding immunotherapy could increase 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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 148 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2031
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 to 65 years
- 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: * Age: 18 - 65 years old * Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing squamous cell carcinoma. * AJCC/UICC 9th edition stage II - III; excluding patients with T3N0M0 (only posterior pharyngeal lymph node metastasis) and T3N1M0. * Baseline plasma EBV-DNA \> 0, and able to complete dynamic monitoring according to the protocol. * ECOG 0 - 1. * Main organ functions meet the requirements: neutrophils ≥ 2.0×10\^9/L, platelets ≥ 100×10\^9/L, hemoglobin ≥ 90 g/L; ALT/AST ≤ 1.5×ULN, total bilirubin ≤ 1.5×ULN; creatinine clearance rate ≥ 60 mL/min. * Signed informed consent form, willing to complete the study according to the protocol. Exclusion Criteria: * Clinical or imaging examinations have confirmed distant metastasis. * Before the diagnosis of nasopharyngeal carcinoma, the patient had received chemotherapy, targeted therapy, or immunotherapy, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic biopsies). * Has an active autoimmune disease, but the following conditions are excluded: type 1 diabetes, hypothyroidism receiving replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia). * Active hepatitis B with poor control of HBV DNA, active hepatitis C, HIV infection or uncontrolled infection. * Within 4 weeks before signing the informed consent form, the patient had used systemic glucocorticoids (equivalent to prednisone dose \> 10mg/day) or other immunosuppressive treatments; if the patient's systemic glucocorticoid dose is equivalent to prednisone ≤ 10mg/day or only uses inhaled or topical glucocorticoids, participation is allowed. * Has a history of active tuberculosis (Mycobacterium tuberculosis infection) in the past year; if active tuberculosis has been fully treated and has been over one year ago, participation is allowed. * Has a history of interstitial lung disease. * Has received live vaccines within 4 weeks before signing the informed consent form, or is about to receive live vaccines in the near future. * Pregnant or lactating women, or reproductive-aged subjects who do not agree to take effective contraceptive measures. * Has a history of other malignant tumors within the past 5 years, but the following situations are excluded: cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, papillary thyroid carcinoma, etc. * Cannot take oral medications or have a known severe allergy to capecitabine, tislelizumab, or cisplatin/gemcitabine. * Has any other conditions, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infections requiring systemic treatment, mental illness or family/social factors, which the investigator believes may affect the patient's ability to sign the informed consent form, cooperate and participate in the study, or interfere with the interpretation of the study results.
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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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Fudan Universtiy Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- DNA blood test may spot nasopharyngeal cancer earlier than current methods
- Million-Person quest to catch a silent cancer early
- Can a new drug combo shrink High-Risk throat tumors?
- Can a lower radiation dose still beat nasopharyngeal cancer?