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

Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05484375

Collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other), Hunan Cancer Hospital (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Nasopharyngeal Carcinoma	Drug: Capecitabine plus toripalimab	Phase 2

Detailed Description

This study is 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. Patients received a standard dose of toripalimab combined with gemcitabine/cisplatin every 3 weeks (Q3W) for 4-6 cycles. Efficacy was assessed after 4-6 courses of chemotherapy, and patients with PR/CR were enrolled in the clinical trial for maintenance therapy. During maintenance therapy, 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Gemcitabine/Cisplatin Plus Toripalimab Treatment: a Single Arm, Open Label, Multicenter, Phase II Clinical Study

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2027

Anticipated Study Completion Date :

Sep 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Capecitabine plus toripalimab maintenance therapy 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 Capecitabine tablet: 650mg/m2, orally, twice a day, d1-d21, every 3 weeks Toripalimab: 240mg, intravenous drip, d1, every 3 weeks

Arm

Intervention/Treatment

Experimental: Capecitabine plus toripalimab maintenance therapy

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

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

Outcome Measures

Primary Outcome Measures

progression-free survival(PFS) [up to 24 month]
The time is defined from the enrolment to progression or death from any cause

Secondary Outcome Measures

overall survival(OS) [up to 24 month]
The time is defined from the enrolment to death from any cause
Objective Response Rate(ORR) [up to 24 month]
The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1
Disease Control Rate (DCR) [up to 24 month]
The proportion of patients who have achieved complete response，partial response and Stable disease assessed by investigators according to Recist v 1.1
Duration of Response (DoR) [up to 24 month]
The time is defined from first documented objective response to radiographic disease progression or death, whichever occurred first, assessed by investigator
Adverse Events (AEs) [up to 24 month]
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.
Peripheral nerves which was graded as≥ 2 according to NCI-CTCAE
Major cardiovascular diseases