Clinical Study of Nab-paclitaxel Combined With Toripalimab in Local Advanced or Metastatic G/GEJ Carcinoma

June 20, 2020 updated by: Yunpeng Liu, China Medical University, China

Albumin-bound Paclitaxel Combined With Toripalimab as First-line/Second-line Treatment of Local Advanced or Metastatic Gastric or Gastroesophageal Junction Carcinoma: A Prospective, Open-label, Single-arm Phase II Clinical Study

This study is to evaluate the efficacy and safety of Albumin-bound paclitaxel combined with Toripalimab as first-line/second-line treatment of local advanced or metastatic gastric or gastroesophageal junction carcinoma.

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.

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 (Anticipated)

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.
44

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.
  • Not Applicable

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 Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110010

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age:18-70 years old, female or male.
  • Histopathologically diagnosed local advanced or metastatic gastric or gastroesophageal junction carcinoma, HER2 negative.
  • At least one measurable lesion according to RECIST 1.1.
  • ≤1 prior line. adjuvant/neoadjuvant therapy is allowed, adjuvant/neoadjuvant therapy is considered as the first-line treatment for advanced diseases, if recurrence occurs during the treatment or within 6 months after the last treatment. prior chemotherapy combined with targeted therapy is allowed.
  • ECOG performance status of 0 or 1.
  • Adequate organ and bone marrow function: ANC≥1.5×109/L, PLT≥90×109/L, HGB≥90g/L,TBil≤1.5ULN, ALT≤2.5ULN, AST≤2.5ULN, Serum Cr≤1ULN, endogenous creatinine clearance>60ml/min (Cockcroft-Gault formula).
  • The international normalized ratio (INR) ≤ 1.5 and some prothrombin time (PPT or APTT) ≤ 1.5ULN within 7 days before enrollment.
  • Expected survival≥3 months.
  • Signed informed consent (ICF) before enrollment.
  • Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment and have a negative result and are willing to use effective and reliable contraceptive methods during and 6 months after the last treatment.

Exclusion Criteria:

  • History of severe allergic reactions to chimeric or humanized antibodies or fusion proteins, or known allergic to any component of Toripalimab or any component of Albumin Bound paclitaxel.
  • severe hypersensitivity after previous administration of monoclonal antibody.
  • ≥1 prior line therapy after progression.
  • Prior therapy with PD-1、PD-L1/L2、CTLA-4 antibody, or any other immunotherapy.
  • A history of organ transplantation.
  • Any other malignancy within 5 years excluding healed Basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of cervical or breast.
  • Received anti-tumor vaccine or other immune-stimulating agents (interferon, interleukin, thymosin, immuno cell therapy, etc.) within 1 month before the first treatment.
  • Symptomatic central nervous system metastases.
  • Acute or chronic Active hepatitis B or hepatitis C.
  • Interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, pulmonary fibrosis, severely impaired lung function and other pulmonary diseases.
  • Active tuberculosis, receiving anti-TB treatment or have received anti-TB treatment within 1 year prior to first treatment.
  • Human immunodeficiency virus (HIV) infection（HIV antibody positive）, or known syphilis infection.
  • Severe uncontrolled disease, non-metastatic systemic disease, active or poor clinical control infection.
  • Patients with autoimmune diseases or abnormal immune system.
  • Treatment with immunosuppressive medications within 4 weeks prior to enrollment. Nasal spray, inhalation, or other ways of topical corticosteroids or systemic corticosteroids at physiologic doses （not to exceed 10 mg/day of prednisone or its equivalent Steroids）are not included.
  • Expected to require any other form of antitumor therapy while on study (including maintenance therapy with any other drugs for gastric or gastroesophageal junction carcinoma、radiotherapy and/or surgical resection)
  • Received major surgery or radiation therapy of > 30 Gy not to chest within 4 weeks of the first treatment, or radiation therapy of > 30 Gy to chest within 24 weeks of the first treatment,or radiation therapy of < 30 Gy to chest within 2 weeks of the first treatment, and had not recovered from the toxicity and/or complications of the most recent prior chemotherapy to Grade 1 or less (except alopecia or fatigue).
  • Poorly Controlled Diabetes（fasting blood-glucose ≥CTCAE grade 2）.
  • Clinically significant thyroid dysfunction and can't maintain thyroid hormone levels in the normal range with drugs.
  • Use of any live vaccines within 4 weeks before enrollment.
  • Pregnant or lactating subjects.
  • Participated in any other drug clinical study within 4 weeks before the enrollment.
  • Any other disease、metabolic disorders、Physical examination or laboratory abnormalities that might result in contraindications in the use of experimental drugs or affect the reliability of the study, or Puts patients at high risk.
  • The investigator believes are not suitable for participating in the study.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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.
EXPERIMENTAL: Albumin-bound Paclitaxel Combined With Toripalimab
  • Albumin-bound Paclitaxel：125mg/m2 IV d1、8，Q3W
  • Toripalimab：240 mg，IV d1，Q3W
  • until disease progression, lost follow-up visit, death , unacceptable toxicity, Maximum treatment duration of Toripalimab is 24 months
Drug: Albumin-Bound Paclitaxel
  • 125mg/m2 IV d1、8，Q3W
  • until disease progression, lost follow-up visit, death , unacceptable toxicity
Other Names:
  • Paclitaxel (albumin-bound)
  • Paclitaxel for injection(Albumin Bound)
Drug: Toripalimab
  • 240 mg，IV d1，Q3W
  • until disease progression, lost follow-up visit, death , unacceptable toxicity, Maximum treatment duration is 24 months

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
PFS
Time Frame: up to 24 months
  • Progression-Free Survival
  • Defined as the time from first dose of study medication to the first documented disease progression per RECIST version 1.1，or death from any cause, whichever occurred first
up to 24 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
ORR
Time Frame: up to 24 months
  • Objective Response Rate
  • Defined as the proportion of patients with confirmed complete response /partial response per RECIST version 1.1
up to 24 months
DCR
Time Frame: up to 24 months
  • Disease control rate
  • Defined as the proportion of patients with confirmed complete response /partial response/ Stable Disease per RECIST version 1.1
up to 24 months
OS
Time Frame: up to 24 months
  • Over survival
  • Defined as the time from the date of first dose of study medication to the date of death from any cause
up to 24 months
Change in Quality of Life(QoL)：measured by EORTC QLQ-C30 questionnaire
Time Frame: up to 24 months
  • European Organisation for Research and Treatment of Cancer's Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
  • The change in the quality of life as measured by EORTC QLQ-C30, consists of 30 questions that provide a global QoL scale, five functional scales (physical, role-playing, emotional, cognitive, social), three symptom scales (fatigue, nausea and vomiting, pain) and six individual factors (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). The scores of each scale are calculated in a score ranging from 0 to 100. A high score on a functional scale represents a good level of function.
up to 24 months
Adverse events
Time Frame: up to 24 months
- Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
up to 24 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.
China Medical University, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yunpeng Liu, PhD., First Hospital of China Medical 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.
June 11, 2020

Primary Completion (ANTICIPATED)

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.
December 30, 2022

Study Completion (ANTICIPATED)

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.
December 30, 2023

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).
June 19, 2020

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.
June 20, 2020

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.
June 23, 2020

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.
June 23, 2020

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.
June 20, 2020

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.
June 1, 2020

More Information

Terms related to this study

Keywords

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.
  • GC-ATJogress

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings