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

Condition	Gastric Carcinoma
Age	18years - 70years
Treatment	Toripalimab, Albumin-Bound Paclitaxel
Clinical Study Identifier	NCT04443036
Sponsor	China Medical University, China
Last Modified on	19 February 2024

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

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