Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Treatment

Official title

Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Gemcitabine/Cisplatin Plus Toripalimab Treatment: a Single Arm, Open Label, Multicenter, Phase II Clinical Study

Overview

to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab.

Detailed description

This study is to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab. Patients received a standard dose of toripalimab combined with gemcitabine/cisplatin every 3 weeks (Q3W) for 4-6 cycles. Efficacy was assessed after 4-6 courses of chemotherapy, and patients with PR/CR were enrolled in the clinical trial for maintenance therapy. During maintenance therapy, capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached.

Interventions

• Drug Capecitabine plus toripalimab
  Capecitabine tablet: 650mg/m2, orally, twice a day, d1-d21, every 3 weeks Toripalimab: 240mg, intravenous drip, d1, every 3 weeks

Primary outcome measures

• progression-free survival(PFS) [Time frame: up to 24 month]

Secondary outcome measures (5)

• overall survival(OS) [Time frame: up to 24 month]
• Objective Response Rate(ORR) [Time frame: up to 24 month]
• Disease Control Rate (DCR) [Time frame: up to 24 month]
• Duration of Response (DoR) [Time frame: up to 24 month]
• Adverse Events (AEs) [Time frame: up to 24 month]

Eligibility criteria

Inclusion criteria

• Histology confirmed metastatic nasopharyngeal carcinoma following radical treatment（Stage IVb, AJCC/UICC 8th，any T，any N，M1）
• Patients receiving gemcitabine/cisplatin in combination with terriprizumab received complete response (CR) or partial response (PR) after 4-6 cycles of imaging studies
• Age ≥18 years and ≤65 years
• WBC≥4×10\^9/L, platelet ≥ 100×10\^9/L, hemoglobin ≥ 90g/L and Albumin≥28 g/L
• With normal liver function test (TBIL#ALT#AST ≤ 2.5×uln) (patients with liver metastasis≤5×uln)
• With normal renal function test (creatinine ≤ 1.5×uln or CCR ≥ 60ml/min)
• ECOG score is 0-1
• At least one measurable lesion according to RECIST v 1.1 (prior to gemcitabine/cisplatin plus toripalimab)
• Life expectancy is at least 12 weeks
• Patients sign informed consent forms

Exclusion criteria

• History of severe anaphylaxis to any component of capecitabine or toripalimab
• Active or untreated central nervous system metastases
• Patient with necrotic lesions and judged by the investigator to be at risk of excessive bleeding
• Patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelled catheters are allowed to participate.
• Patients with poorly controlled or symptomatic hypercalcemia
• Pregnancy or lactation
• Malignancies other than nasopharyngeal carcinoma, with negligible risk of metastasis or death and radical outcome expected after treatment, within the 5 years prior to enrollment.
• Patients who have previously received allogeneic bone marrow transplants or solid organ transplants.
• History of autoimmune diseases
• Received systemic immunostimulant therapy (except toripalimab in palliative chemotherapy, including but not limited to interferon or IL-2) within 4 weeks prior to enrollment or during 5 half-lives of the drug.
• Receive any active vaccine within 4 weeks prior to enrollment
• Basic medical conditions that the investigator identified as likely to affect significantly drug administration and protocol adherence of the study
• Active pneumonia
• Active infections, including tuberculosis, hepatitis B, hepatitis C or HIV.
• Presence of severe neurological or psychiatric disorders, including dementia and seizures.
• Peripheral nerves which was graded as≥ 2 according to NCI-CTCAE
• Major cardiovascular diseases

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05484375 · IIT-2022-017(FL5)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗