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Gastric CarcinomaNCT04443036

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

A study testing Albumin-Bound Paclitaxel and Toripalimab in people with Gastric Carcinoma, run by China Medical University, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastric Carcinoma
What is being tested?
Albumin-Bound Paclitaxel and Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
11 Jun 2020to 30 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Yunpeng Liu, PhD. contact

86-24-83282312

cmuliuyunpeng@hotmail.com

Xiujuan Qu, PhD. contact

86-24-83282542

qu_xiujuan@hotmail.com

China1 site, 1 recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110010

    Yunpeng Liu, PhD., 86-24-83282312, cmuliuyunpeng@hotmail.com

    Xiujuan Qu, PhD., 86-24-83282542, qu_xiujuan@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Albumin-Bound Paclitaxel, Toripalimab
Keywords
gastric carcinoma, gastroesophageal junction carcinoma, Albumin Bound Paclitaxel, Toripalimab
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Albumin-Bound PaclitaxelDrug

    Also called Paclitaxel (albumin-bound), Paclitaxel for injection(Albumin Bound)

    • 125mg/m2 IV d1、8，Q3W
    • until disease progression, lost follow-up visit, death , unacceptable toxicity

  • ToripalimabDrug

    • 240 mg，IV d1，Q3W
    • until disease progression, lost follow-up visit, death , unacceptable toxicity, Maximum treatment duration is 24 months
Study groups in NCT04443036
Study groupRoleWhat they receive
Albumin-bound Paclitaxel Combined With ToripalimabExperimental* 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
Receives: Drug: Albumin-Bound Paclitaxel; Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    • 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

    Measured: up to 24 months

Secondary outcomes (5)

  1. ORR

    • Objective Response Rate
    • Defined as the proportion of patients with confirmed complete response /partial response per RECIST version 1.1

    Measured: up to 24 months

  2. DCR

    • Disease control rate
    • Defined as the proportion of patients with confirmed complete response /partial response/ Stable Disease per RECIST version 1.1

    Measured: up to 24 months

  3. OS

    • Over survival
    • Defined as the time from the date of first dose of study medication to the date of death from any cause

    Measured: up to 24 months

  4. Change in Quality of Life(QoL)：measured by EORTC QLQ-C30 questionnaire

    • 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.

    Measured: up to 24 months

  5. Adverse events

    • Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2020
  2. Study start11 Jun 2020
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04443036
Sponsor's protocol ID
GC-ATJogress
Status last verified
Jun 2020
First submitted
19 Jun 2020
Last updated
23 Jun 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Albumin-Bound Paclitaxel and Toripalimab in people with Gastric Carcinoma, run by China Medical University, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yunpeng Liu, PhD. (86-24-83282312, cmuliuyunpeng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04443036.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.

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