Nasopharyngeal CarcinomaPhase 2NCT07331428
MRG003 Induction and Capecitabine Maintenance With PD-1 in Locally Recurrent NPC
A Phase 2 study testing MRG003, Tislelizumab and Capecitabine in people with Nasopharyngeal Carcinoma and Local Recurrence, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
This study enrolls patients who have experienced local recurrence of nasopharyngeal carcinoma (NPC) with or without regional recurrence. The treatment regimen includes an induction phase with MRG003 at 2.0 mg/kg (D1) combined with Tislelizumab 200 mg (D1), administered weekly for 6 cycles. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Local Recurrence
- What is being tested?
- MRG003, Tislelizumab and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2026to 31 Dec 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age 18-70 years.
- Pathologically confirmed local recurrence of NPC, staged as rT1-rT4 according to the 9th edition of the AJCC/UICC classification.
- ECOG performance status score of 0-1.
- No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent NPC.
- No contraindications to immunotherapy or chemotherapy.
- Adequate organ function.
Who cannot join
- Previous treatment with other PD-1 antibodies or immunotherapy targeting PD-1/PD-L1 resulting in Grade III or higher immune-related adverse reactions.
- 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).
- 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).
- Known allergy to MRG003, capecitabine, or any component of anti-PD-1 antibodies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
Qiaojuan Guo, PhD, (86) 591-83638732, guoqiaojuan@163.com
About this study
Official title: Efficacy and Safety of MRG003 With PD-1 Induction Followed by Capecitabine and PD-1 Maintenance as First-line Treatment in Locally Recurrent Nasopharyngeal Carcinoma
This study enrolls patients who have experienced local recurrence of nasopharyngeal carcinoma (NPC) with or without regional recurrence. The treatment regimen includes an induction phase with MRG003 at 2.0 mg/kg (D1) combined with Tislelizumab 200 mg (D1), administered weekly for 6 cycles. This is followed by maintenance therapy consisting of Capecitabine (650 mg/m², twice daily on days 1-21) in combination with Tislelizumab, continued for up to 1 year or until disease progression.
- Conditions
- Nasopharyngeal Carcinoma, Local Recurrence
- Being tested
- MRG003, Tislelizumab, Capecitabine
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG003Drug
MRG003 at 2.0 mg/kg (D1) will be administered every three weeks for 6 cycles
TislelizumabDrug
Tislelizumab 200 mg (D1) will be administered every three weeks for 6 cycles. Upon achieving an objective response, maintenance therapy will continue for up to one year or until disease progression is observed.
CapecitabineDrug
After achieving an objective response (ORR) with the combination of MRG003 and Tislelizumab, maintenance therapy will consist of Capecitabine (650 mg/m², administered twice daily on Days 1-21) in conjunction with Tislelizumab. This maintenance phase will continue for up to one year or until disease progression is observed.
| Study group | Role | What they receive |
|---|---|---|
| MRG003 | Experimental | The treatment regimen comprises an induction phase with MRG003 at 2.0 mg/kg (administered on Day 1) in combination with Tislelizumab 200 mg (also on Day 1), delivered every three weeks for a total of six cycles. Upon achieving an objective response (ORR), patients will proceed to maintenance therapy, which consists of Capecitabine (650 mg/m², administered twice daily on Days 1-21) in conjunction with Tislelizumab. This maintenance phase will continue for up to one year or until disease progression is observed. Receives: Drug: MRG003; Drug: Tislelizumab; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The Objective Response Rate (ORR) is defined as the proportion of patients achieving Complete Response (CR) or Partial Response (PR) by Day 21 after the completion of six cycles of MRG003 treatment, starting from the date of enrollment.
Measured: Day 21 after the completion of six cycles of MRG003 treatment
Secondary outcomes (4)
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to the date of tumor progression or death from any cause, or to the date of the last follow-up if no progression has occurred.
Measured: 1-year; 3-year
Overall Survival (OS)
OS is defined as the time from enrollment to the date of death from any cause, or to the date of the last follow-up if no death has occurred.
Measured: 1-year; 3-year
Duration of Response (DOR)
DOR is defined as the time from the first assessment of Complete Response (CR) or Partial Response (PR) to the first assessment of Progressive Disease (PD) or death from any cause
Measured: 1-year; 3-year
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after treatment.
Measured: Day 21 after the completion of six cycles of MRG003 treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start16 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The treatment regimen includes an induction phase with MRG003 at 2.0 mg/kg (D1) combined with Tislelizumab 200 mg (D1), administered weekly for 6 cycles. This is followed by maintenance therapy consisting of Capecitabine (650 mg/m², twice daily on days 1-21) in combination with Tislelizumab, continued for up to 1 year or until disease progression.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Qiaojuan Guo, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331428
- Sponsor's protocol ID
- 2025-12-19
- Status last verified
- Oct 2026
- First submitted
- 28 Dec 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No