Adjuvant Sintilimab Plus Capecitabine in Nasopharyngeal Carcinoma (NCT05201859) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Adjuvant Sintilimab Plus Capecitabine in Nasopharyngeal Carcinoma
China150 participantsStarted 2022-05-17
Plain-language summary
This randomized clinical trial determining whether Sintilimab plus Capecitabine versus Capecitabine alone can improve the progression-free survival rate of NPC patients with unfavorable response to induction chemotherapy. Patients whose plasma EBV DNA\> 0 copy/mL or SD/PD according to RECIST1.1 after two cycles induction chemotherapy will have concurrent chemoradiotherapy. MRI, CT and EBV DNA will be assessed before the end of radiotherapy. After concurrent chemoradiotherapy, eligible patients will be randomized to receive either adjuvant Sintilimab plus Capecitabine or Capecitabine alone.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III.
✓. Tumor staged as II-IVa (AJCC 8th,excluding T2N0 disease).
✓. Age ≥ 18 years and ≤ 70 years, both genders.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
✓. Patients with plasma EBV DNA\> 0 copy/mL or PD/SD according to RECIST1.1 after two cycles of induction chemotherapy.
✓. Completed protocol-specified curative chemoradiotherapy, including two cycles of induction chemotherapy, intensity-modulated radiotherapy, and concurrent cisplatin chemotherapy( at least 2 cycles of concurrent cisplatin chemotherapy).
✓. Completion of the last radiation dose within 1 to 7 days before randomization
✕. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.
✕. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
✕. Is pregnant or breastfeeding.
✕. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA \>1×10e3 copies/ml or 200IU/ml
✕. Hepatitis C virus (HCV) antibody positive
✕. Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
✕. Has any condition that required systemic corticosteroid (equivalent to prednisone \>10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed.