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

NCT ID: NCT06669611

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-27

Study Completion Date

2029-11-20

Brief Summary

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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.

Detailed Description

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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

Conditions

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Nasopharyngeal Cancinoma (NPC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Camrelizumab with GP chemotherapy

Camrelizumab, cisplatin and gemcitabine

Group Type ACTIVE_COMPARATOR

Camrelizumab combined GP chemotherapy

Intervention Type 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.

camrelizumab with nab-TPC chemotherapy

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

Group Type EXPERIMENTAL

Camrelizumab combined TPC chemotherapy

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Camrelizumab, cisplatin and gemcitabine camrelizumab plus nab-TPC chemotherapy, nab-paclitaxel, cisplatin and capecitabine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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XIANG YANQUN

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SunYat-senU

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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XIANG YANQUN

Role: CONTACT

Phone: 02087343379

Email: [email protected]

Facility Contacts

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Yanqun Xiang, MD

Role: primary

Weixiong Xia, MD

Role: backup

Other Identifiers

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SYSKY-2024-869-01

Identifier Type: -

Identifier Source: org_study_id