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

  • STATUS
    Recruiting
  • participants needed
    44
  • sponsor
    China Medical University, China
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Updated on 19 February 2024
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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.

Details
Condition Gastric Carcinoma
Age 18-70 years
Treatment Toripalimab, Albumin-Bound Paclitaxel
Clinical Study IdentifierNCT04443036
SponsorChina Medical University, China
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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: ANC1.5109/L, PLT90109/L, HGB90g/L,TBil1.5ULN, ALT2.5ULN, AST2.5ULN, Serum Cr1ULN, endogenous creatinine clearance60ml/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 survival3 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
prior line therapy after progression
Prior therapy with PD-1PD-L1/L2CTLA-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) infectionHIV 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 Steroidsare 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 carcinomaradiotherapy 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 Diabetesfasting 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 diseasemetabolic disordersPhysical 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
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