Maintenance Therapy With Toripalimab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma

NCT05869227 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: SYSKY-2023-307-02
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the efficacy and safety of the "capecitabine combined with toripalimab maintenance regimen" in improving the first-line treatment of recurrent and metastatic nasopharyngeal carcinoma after receiving remission through chemotherapy combined with anti PD-1 monoclonal antibody standard regimen.

Conditions

Nasopharyngeal Carcinoma; Maintenance Therapy

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression free survival is defined as the time interval between randomization and the first recording of tumor progression (evaluated according to RECIST 1.1 criteria, regardless of continued treatment) or death from any cause

  2 years

Study Arms (2)

Capecitabine combined with toripalimab maintenance group

EXPERIMENTAL

Capecitabine, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle toripalimab, 240mg, intravenously, day 1 and 21 days/cycle

Drug: Capecitabine/Placebo combined with toripalimab

Placebo combined with toripalimab maintenance group

PLACEBO COMPARATOR

Placebo, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle toripalimab, 240mg, intravenously, day 1 and 21 days/cycle

Drug: Capecitabine/Placebo combined with toripalimab

Interventions

Capecitabine/Placebo combined with toripalimab DRUG

Combined

Capecitabine combined with toripalimab maintenance group; Placebo combined with toripalimab maintenance group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age at the time of diagnosis is 18-75 years old, regardless of gender;
• Histologically confirmed nasopharyngeal carcinoma;
• Confirm the presence of distant metastasis in advanced nasopharyngeal carcinoma patients or recurrent nasopharyngeal carcinoma patients who cannot receive local treatment. ;
• After receiving standard treatment for 4-6 cycles, the disease is control;
• ECOG score 0-1;
• Expected survival time of at least 12 weeks;
• Patients who have not received systemic chemotherapy within 6 months prior to diagnosis ;
• According to RECIST 1.1 standard, at least 1 measurable lesion;
• Enough organ function;
• Sign an informed consent form;
• Female participants with fertility and male participants with fertility partners must agree to use reliable contraceptive measures within 6 months after screening and the last treatment.

You may not qualify if:

• Patients who are known to be intolerant to capecitabine or allergic to any therapeutic drug, or who are participating in clinical studies of other new drugs;
• Diseases that may interfere with oral medication treatment, including but not limited to swallowing difficulties, chronic diarrhea, or intestinal obstruction;
• Previous or current history of other tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, and thyroid papillary carcinoma;
• Sever heart disease;
• Central nervous system metastasis with clinical symptoms;
• Serious infections ;
• Within 4 weeks of signing the informed consent form, receive systemic hormone or other immunosuppressive therapy with an equivalent dose greater than 10mg prednisone per day. Subjects with a systemic hormone dose ≤ 10mg prednisone per day or inhaled/topical corticosteroids can be enrolled in the study;
• Patients with active chronic hepatitis B or active hepatitis C.
• A history of interstitial pneumonia or other autoimmune diseases.
• HIV infection;
• Individuals with significant organ dysfunction or uncontrollable comorbidities, including but not limited to uncontrollable hypertension, decompensated liver cirrhosis, active peptic ulcer, or hemorrhagic disease;
• Less than 6 weeks after major organ surgery;
• Pregnant or breast feeding;
• Patients with mental illness, those with a history of alcohol or drug abuse, or those who are unable to obtain informed consent;
• Other researchers have determined that it is not suitable to participate in this trial.

Sponsors & Collaborators

• XIANG YANQUN: lead
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Zhujiang Hospital: collaborator

Study Sites (1)

SunYat-senU

Guangzhou, Guangdong, 510060, China

Location

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: April 28, 2023
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)