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

Phase 3

Active, not recruiting

• Conditions: Nasopharyngeal Carcinoma; Maintenance Therapy
• Interventions: Drug: Capecitabine/Placebo combined with toripalimab

• Registration Number: NCT05869227
• Lead Sponsor: XIANG YANQUN

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-28
• Study First Submitted: 2023-05-11
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30
• Primary Completion: 2027-12-20
• Study Completion: 2027-12-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 166

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo combined with toripalimab maintenance group	Capecitabine/Placebo combined with toripalimab	Placebo, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle toripalimab, 240mg, intravenously, day 1 and 21 days/cycle
Capecitabine combined with toripalimab maintenance group	Capecitabine/Placebo combined with toripalimab	Capecitabine, 1000 mg/m2/dose, twice a day, days 1-14; 21 days/cycle toripalimab, 240mg, intravenously, day 1 and 21 days/cycle

Primary Outcome Measures

Name	Time	Method
Progression free survival	2 years	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

Trial Locations

Locations (1)

SunYat-senU; 🇨🇳 Guangzhou, Guangdong, China