New combo therapy aims to control returning throat cancer
NCT ID NCT07331428
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a two-step treatment for people whose nasopharyngeal cancer has come back after initial treatment. First, patients receive a targeted drug (MRG003) plus an immunotherapy (PD-1) for six weeks. Then, they take a chemotherapy pill (capecitabine) with the immunotherapy for up to a year. The goal is to shrink or control the tumor. The study involves 25 adults aged 18-70 with locally recurrent cancer but no spread to other organs.
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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 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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 70 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: \*\*Inclusion Criteria:\*\* 1. Patients with locally recurrent nasopharyngeal carcinoma (NPC) more than 1 year after initial radical treatment for non-metastatic NPC, with or without regional recurrence, but without distant metastasis. 2. Age 18-70 years. 3. Pathologically confirmed local recurrence of NPC, staged as rT1-rT4 according to the 9th edition of the AJCC/UICC classification. 4. ECOG performance status score of 0-1. 5. No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent NPC. 6. No contraindications to immunotherapy or chemotherapy. 7. Adequate organ function. Exclusion Criteria: \*\*Exclusion Criteria:\*\* 1. Previous treatment with other PD-1 antibodies or immunotherapy targeting PD-1/PD-L1 resulting in Grade III or higher immune-related adverse reactions. 2. Residual toxic effects from prior anti-tumor treatments (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy) (excluding alopecia, fatigue, and Grade 2 hypothyroidism) or clinically significant laboratory abnormalities higher than Grade 1 (CTCAE v5.0). 3. Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥10 copies/ml), or hepatitis C (positive hepatitis C antibody and HCV-RNA above the detection limit of the assay). 4. Known allergy to MRG003, capecitabine, or any component of anti-PD-1 antibodies.
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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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a targeted drug outperform chemotherapy in Tough-to-Treat nasopharyngeal cancer?
- Can an experimental drug shrink advanced solid tumors?
- Can a targeted therapy replace harsh chemo in nasopharyngeal cancer?
- Could adding extra chemo before standard therapy beat nasopharyngeal cancer?
- Smart T-Cell engager aims to outsmart tumors in first human test
- Immunotherapy combo shows promise in shrinking Hard-to-Treat head and neck tumors