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

The Efficacy and Safety of Maintenance Therapy With Toripalimab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma:Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nasopharyngeal Carcinoma; Maintenance Therapy
• Intervention / Treatment: Drug: Capecitabine/Placebo combined with toripalimab

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • SunYat-senU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The age at the time of diagnosis is 18-75 years old, regardless of gender;
2. Histologically confirmed nasopharyngeal carcinoma;
3. Confirm the presence of distant metastasis in advanced nasopharyngeal carcinoma patients or recurrent nasopharyngeal carcinoma patients who cannot receive local treatment. ;
4. After receiving standard treatment for 4-6 cycles, the disease is control;
5. ECOG score 0-1;
6. Expected survival time of at least 12 weeks;
7. Patients who have not received systemic chemotherapy within 6 months prior to diagnosis ;
8. According to RECIST 1.1 standard, at least 1 measurable lesion;
9. Enough organ function;
10. Sign an informed consent form;
11. 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.

Exclusion Criteria:

1. 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;
2. Diseases that may interfere with oral medication treatment, including but not limited to swallowing difficulties, chronic diarrhea, or intestinal obstruction;
3. Previous or current history of other tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, and thyroid papillary carcinoma;
4. Sever heart disease;
5. Central nervous system metastasis with clinical symptoms;
6. Serious infections ;
7. 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;
8. Patients with active chronic hepatitis B or active hepatitis C.
9. A history of interstitial pneumonia or other autoimmune diseases.
10. HIV infection;
11. Individuals with significant organ dysfunction or uncontrollable comorbidities, including but not limited to uncontrollable hypertension, decompensated liver cirrhosis, active peptic ulcer, or hemorrhagic disease;
12. Less than 6 weeks after major organ surgery;
13. Pregnant or breast feeding;
14. Patients with mental illness, those with a history of alcohol or drug abuse, or those who are unable to obtain informed consent;
15. Other researchers have determined that it is not suitable to participate in this trial.
16. Those who refuse or are unable to sign the informed consent form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capecitabine combined with toripalimab maintenance group; 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; Combined
Placebo Comparator: Placebo combined with toripalimab maintenance group; 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; Combined

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: XIANG YANQUN
• Collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 20, 2027

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Carcinoma; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Capecitabine
• Other Study ID Numbers: SYSKY-2023-307-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No