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

December 26, 2024 updated by: XIANG YANQUN, Sun Yat-sen University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
242

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: 15 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 1,3,5 years
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
Time Frame: 3 months
Adverse events occurring during chemotherapy
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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