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

NCT04443036 | Unknown

• 1 other identifier: GC-ATJogress
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Carcinoma

Keywords

gastric carcinoma; gastroesophageal junction carcinoma; Albumin Bound Paclitaxel; Toripalimab

Outcome Measures

Primary Outcomes (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

  up to 24 months

Secondary Outcomes (5)

• ORR

  up to 24 months

• DCR

  up to 24 months

• OS

  up to 24 months

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

  up to 24 months

• Adverse events

  up to 24 months

Study Arms (1)

Albumin-bound Paclitaxel Combined With Toripalimab

EXPERIMENTAL

* 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; Drug: Toripalimab

Interventions

Albumin-Bound Paclitaxel DRUG

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

Also known as: Paclitaxel (albumin-bound), Paclitaxel for injection(Albumin Bound)

Albumin-bound Paclitaxel Combined With Toripalimab

Toripalimab DRUG

* 240 mg，IV d1，Q3W * until disease progression, lost follow-up visit, death , unacceptable toxicity, Maximum treatment duration is 24 months

Albumin-bound Paclitaxel Combined With Toripalimab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, 110010, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Albumin-Bound Paclitaxel; Taxes; Paclitaxel; toripalimab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations

Study Officials

• Yunpeng Liu, PhD.

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunpeng Liu, PhD.

CONTACT

86-24-83282312; cmuliuyunpeng@hotmail.com

Xiujuan Qu, PhD.

CONTACT

86-24-83282542; qu_xiujuan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Medical Oncology

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: June 11, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: June 23, 2020

Record last verified: 2020-06

Locations

CN (1)