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

Nab-TPC Versus GP Chemotherapy Combined With Camrelizumab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma: Randomized Controlled, Multi Center, Phase III Clinical Study

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.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Cancinoma (NPC)
• Intervention / Treatment: Drug: Camrelizumab combined GP chemotherapy; Drug: Camrelizumab combined TPC chemotherapy

Detailed Description

The therapeutic effect of patients with metastatic nasopharyngeal carcinoma has been further improved. Numerous previous studies have shown that anti-PD-1 immune checkpoint inhibitors (ICIs) have strong activity in treated metastatic nasopharyngeal carcinoma patients, with an objective response rate (ORR) of 20-34%. In addition, immunotherapy has also achieved good results in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma. In 2021, the clinical results of a study on the treatment of recurrent/metastatic nasopharyngeal carcinoma with pembrolizumab were published. The median PFS of the pembrolizumab combined with chemotherapy group was 9.7 months, significantly prolonging PFS, with an HR value of 0.54, and reducing the risk of disease progression by 46%. Based on this, the 2022 CSCO guidelines will use pembrolizumab combined with GP chemotherapy as a new first-line treatment for metastatic nasopharyngeal carcinoma.We conducted a study comparing the efficacy of GP regimen and nab TPC regimen, and found that nab TPC regimen significantly improved the survival of patients with metastatic nasopharyngeal carcinoma compared to GP regimen, and the nab TPC regimen group had milder grade 3-4 toxic side effects.This study aims to design a prospective phase III clinical trial on the safety and efficacy of GP combined with Carilizumab compared to nab TPC regimen combined with Carilizumab chemotherapy for recurrent and metastatic nasopharyngeal carcinoma

• Study Type: Interventional
• Enrollment (Estimated): 242
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: XIANG YANQUN; Phone Number: 02087343379; Email: xiangyq@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • SunYat-senU
      • Contact: Yanqun Xiang, MD; Phone Number: +86-18666096623; Email: xiangyq@sysucc.org.cn
      • Contact: Weixiong Xia, MD; Phone Number: +86-18520415699; Email: xiawx@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Camrelizumab with GP chemotherapy; Camrelizumab, cisplatin and gemcitabine	Drug: Camrelizumab combined GP chemotherapy; 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.; Other Names: Camrelizumab, cisplatin and gemcitabine
Experimental: camrelizumab with nab-TPC chemotherapy; camrelizumab plus nab-TPC chemotherapy (nab-paclitaxel, cisplatin and capecitabine)	Drug: Camrelizumab combined TPC chemotherapy; 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.; Other Names: camrelizumab plus nab-TPC chemotherapy, nab-paclitaxel, cisplatin and capecitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	The secondary endpoint was OS, which was assessed as the time from randomization to death according to RECIST v1.1 or PERCIST, whichever occurred first.	1,3,5 years
Safety and Adverse Events	Adverse events occurring during chemotherapy	3 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2024
• Primary Completion (Estimated): November 20, 2027
• Study Completion (Estimated): November 20, 2029

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Capecitabine; Gemcitabine; Paclitaxel; Cisplatin
• Other Study ID Numbers: SYSKY-2024-869-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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