Nab-TPC vs GP Combined With Camrelizumab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

NCT06669611 | Recruiting Phase 3 DMC

• 1 other identifier: SYSKY-2024-869-01
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

We expect to conduct a clinical trial in recurrent and metastatic nasopharyngeal carcinoma patients to explore and compare the efficacy and safety of induction chemotherapy (TPC vs. GP) with combination therapy of Camrelizumab.

Conditions

Nasopharyngeal Cancinoma (NPC)

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  The primary endpoint was PFS, which was assessed as the time from randomization to disease progression per RECIST v1.1 assessed by IRC or death, whichever occurred first.

  15 months

Secondary Outcomes (2)

• Overall Survival

  1,3,5 years

• Safety and Adverse Events

  3 months

Study Arms (2)

Camrelizumab with GP chemotherapy

ACTIVE COMPARATOR

Camrelizumab, cisplatin and gemcitabine

Drug: Camrelizumab combined GP chemotherapy

camrelizumab with nab-TPC chemotherapy

EXPERIMENTAL

camrelizumab plus nab-TPC chemotherapy (nab-paclitaxel, cisplatin and capecitabine)

Drug: Camrelizumab combined TPC chemotherapy

Interventions

Camrelizumab combined GP chemotherapy DRUG

Camrelizumab was intravenously given at dose of 200 mg on day 1. The GP regimen included gemcitabine administered at a dose of 1 g/m2 on day 1 and day 8, cisplatin at a dose of 80 mg/m2 on day 1.Q3W 1 cycle, 4-6 cycles.

Also known as: Camrelizumab, cisplatin and gemcitabine

Camrelizumab with GP chemotherapy

Camrelizumab combined TPC chemotherapy DRUG

Camrelizumab was intravenously given at dose of 200 mg on day 1. The TPC regimen included nab-paclitaxel administered at a dose of 200 mg/m2 on day 1, cisplatin at a dose of 60 mg/m2 on day 1, and capecitabine at a dose of 1000 mg/m2, taken orally twice a day on days 1 to 14, for each cycle. Q3W 1 cycle, 4-6 cycles.

Also known as: camrelizumab plus nab-TPC chemotherapy, nab-paclitaxel, cisplatin and capecitabine

camrelizumab with nab-TPC chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years.
• ECOG score of 0-1.
• Expected survival of at least 12 weeks.
• Recurrent/Metastatic Nasopharyngeal Carcinoma.
• At least 4 weeks since the previous chemotherapy.
• At least one (according to RECIST) measurable lesion, lesions that have been previously irradiated can not be considered target lesions.
• had adequate organ function

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

SunYat-senU

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; Cisplatin; Gemcitabine; 130-nm albumin-bound paclitaxel; Capecitabine

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

XIANG YANQUN

CONTACT

02087343379; xiangyq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 1, 2024
• Study Start: November 27, 2024
• Primary Completion (Estimated): November 20, 2027
• Study Completion (Estimated): November 20, 2029
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)