Nasopharyngeal Carcinoma, Local Recurrence
Conditions
Brief 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. 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.
Interventions
DRUGMRG003
MRG003 at 2.0 mg/kg (D1) will be administered every three weeks for 6 cycles
DRUGTislelizumab
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.
DRUGCapecitabine
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.
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
\*\*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | Day 21 after the completion of six cycles of MRG003 treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 1-year; 3-year | 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. |
| Progression-Free Survival (PFS) | 1-year; 3-year | 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. |
| Duration of Response (DOR) | 1-year; 3-year | 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 |
| Disease Control Rate (DCR) | Day 21 after the completion of six cycles of MRG003 treatment | DCR is defined as the proportion of subjects who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after treatment. |
Outcome results
None listed