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

NCT05484375 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: IIT-2022-017(FL5)
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metastatic Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinoma; capecitabine; toripalimab; maintenance therapy

Outcome Measures

Primary Outcomes (1)

• progression-free survival(PFS)

  The time is defined from the enrolment to progression or death from any cause

  up to 24 month

Secondary Outcomes (5)

• overall survival(OS)

  up to 24 month

• Objective Response Rate(ORR)

  up to 24 month

• Disease Control Rate (DCR)

  up to 24 month

• Duration of Response (DoR)

  up to 24 month

• Adverse Events (AEs)

  up to 24 month

Study Arms (1)

Capecitabine plus toripalimab maintenance therapy

EXPERIMENTAL

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.

Drug: Capecitabine plus toripalimab

Interventions

Capecitabine plus toripalimab DRUG

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

Capecitabine plus toripalimab maintenance therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: lead
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Hunan Cancer Hospital: collaborator

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Capecitabine; toripalimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Yin Wen-Jing

  Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Yin Wen-Jing

CONTACT

0086-13929503157; wenjing1342@163.com

Liu Jin-Quan

CONTACT

0086-137-1086-6485; 609149209@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: July 30, 2022
• First Posted: August 2, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 2, 2022

Record last verified: 2022-07