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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: Capecitabine plus toripalimab

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yin Wen-Jing; Phone Number: 0086-13929503157; Email: wenjing1342@163.com
• Study Contact Backup: Name: Liu Jin-Quan; Phone Number: 0086-137-1086-6485; Email: 609149209@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histology confirmed metastatic nasopharyngeal carcinoma following radical treatment（Stage IVb, AJCC/UICC 8th，any T，any N，M1）
2. Patients receiving gemcitabine/cisplatin in combination with terriprizumab received complete response (CR) or partial response (PR) after 4-6 cycles of imaging studies
3. Age ≥18 years and ≤65 years
4. WBC≥4×10^9/L, platelet ≥ 100×10^9/L, hemoglobin ≥ 90g/L and Albumin≥28 g/L
5. With normal liver function test (TBIL#ALT#AST ≤ 2.5×uln) (patients with liver metastasis≤5×uln)
6. With normal renal function test (creatinine ≤ 1.5×uln or CCR ≥ 60ml/min)
7. ECOG score is 0-1
8. At least one measurable lesion according to RECIST v 1.1 (prior to gemcitabine/cisplatin plus toripalimab)
9. Life expectancy is at least 12 weeks
10. Patients sign informed consent forms

Exclusion Criteria:

1. History of severe anaphylaxis to any component of capecitabine or toripalimab
2. Active or untreated central nervous system metastases
3. Patient with necrotic lesions and judged by the investigator to be at risk of excessive bleeding
4. Patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelled catheters are allowed to participate.
5. Patients with poorly controlled or symptomatic hypercalcemia
6. Pregnancy or lactation
7. 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.
8. Patients who have previously received allogeneic bone marrow transplants or solid organ transplants.
9. History of autoimmune diseases
10. 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.
11. Receive any active vaccine within 4 weeks prior to enrollment
12. Basic medical conditions that the investigator identified as likely to affect significantly drug administration and protocol adherence of the study
13. Active pneumonia
14. Active infections, including tuberculosis, hepatitis B, hepatitis C or HIV.
15. Presence of severe neurological or psychiatric disorders, including dementia and seizures.
16. Peripheral nerves which was graded as≥ 2 according to NCI-CTCAE
17. Major cardiovascular diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival(PFS)	The time is defined from the enrolment to progression or death from any cause	up to 24 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Collaborators: Hunan Cancer Hospital; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Study Director: Yin Wen-Jing, Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): September 1, 2027
• Study Completion (ANTICIPATED): September 1, 2029

Study Registration Dates

• First Submitted: July 30, 2022
• First Submitted That Met QC Criteria: July 30, 2022
• First Posted (ACTUAL): August 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 30, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: capecitabine; toripalimab; nasopharyngeal carcinoma; maintenance therapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: IIT-2022-017(FL5)

Drug and device information, study documents

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