Status:
RECRUITING
Adjuvant Sintilimab Plus Capecitabine in Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 in...
Detailed Description
Currently, although NCCN (National Comprehensive Cancer Network) guidelines recommend induction chemotherapy combined with concurrent chemoradiotherapy as IIA level-evidenced treatment for nasopharyng...
Eligibility Criteria
Inclusion
- 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
- No progression after prior cCRT
- Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
- Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
- Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
- Patients must be informed of the investigational nature of this study and give written informed consent.
- Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.
Exclusion
- Histologically confirmed keratinizing squamous cell carcinoma (WHO I).
- 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.
- Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed.
- Has known allergy to large molecule protein products or any compound of sintilimab.
- Has a known history of interstitial lung disease.
- Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
Key Trial Info
Start Date :
March 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05201859
Start Date
March 29 2022
End Date
February 15 2026
Last Update
May 6 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060