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

NCT ID: NCT04443036

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-11
• Study Completion Date: 2023-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Albumin-Bound Paclitaxel

Intervention Type: DRUG

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

Toripalimab

Intervention Type: DRUG

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

Interventions

Albumin-Bound Paclitaxel

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

Intervention Type: DRUG

Toripalimab

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

Intervention Type: DRUG

Other Intervention Names

Paclitaxel (albumin-bound); Paclitaxel for injection(Albumin Bound)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Yunpeng Liu

Director of Department of Medical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yunpeng Liu, PhD.

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Locations

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yunpeng Liu, PhD.

Role: CONTACT

cmuliuyunpeng@hotmail.com

86-24-83282312

Xiujuan Qu, PhD.

Role: CONTACT

qu_xiujuan@hotmail.com

86-24-83282542

Facility Contacts

Yunpeng Liu, PhD.

Role: primary

cmuliuyunpeng@hotmail.com

86-24-83282312

Xiujuan Qu, PhD.

Role: backup

qu_xiujuan@hotmail.com

86-24-83282542

Other Identifiers

GC-ATJogress

Identifier Type: -

Identifier Source: org_study_id