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

NCT ID: NCT05869227

Last Updated: 2024-12-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-28
• Study Completion Date: 2027-12-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Capecitabine/Placebo combined with toripalimab

Intervention Type: DRUG

Combined

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

Group Type: PLACEBO_COMPARATOR

Capecitabine/Placebo combined with toripalimab

Intervention Type: DRUG

Combined

Interventions

Capecitabine/Placebo combined with toripalimab

Combined

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Zhujiang Hospital

OTHER

Sponsor Role: collaborator

XIANG YANQUN

OTHER

Sponsor Role: lead

Responsible Party

XIANG YANQUN

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

SunYat-senU

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SYSKY-2023-307-02

Identifier Type: -

Identifier Source: org_study_id