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New treatment option for Gastric/Gastroesophageal Junction Adenocarcinoma
Official title A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT06415669
What this study is testing
What is Paclitaxel for injection (albumin-bound)?
Paclitaxel for injection (albumin-bound) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for gastric/gastroesophageal junction adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the initial efficacy and safety of paclitaxel for injection (albumin-bound) in combination with apatinib mesylate and adebrelimab in the treatment of locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma following the progression of previous immunotherapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1) Age: 18 \~ 75 years old, male and female;
- 2) ECOG score: 0 or 1;
- 3) Patients with unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma confirmed by histopathology;
- 4) Patients who have received at least first-line immunotherapy progression or intolerance in the past, and the number of previous systemic treatment...
- 5) According to the evaluation criteria for the how well it works of solid tumors (RECIST 1.1), there should be at least one measurable lesion that...
You likely can't join if
- 1) Patients who have previously received paclitaxel chemotherapy; Patients with neoadjuvant or adjuvant treatment with taxoid drugs and disease...
- 2) HER2-positive patients;
- 3) Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose \>10mg/ day prednisone or other...
- 4) Patients with severe liver and kidney insufficiency or heart insufficiency;
- 5) have multiple factors that affect oral drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea, and intestinal...
- 6) Patients with brain metastases accompanied by symptoms or symptom control for less than 3 months;
See the full eligibility criteria
Who can join
- 1) Age: 18 \~ 75 years old, male and female;
- 2) ECOG score: 0 or 1;
- 3) Patients with unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma confirmed by histopathology;
- 4) Patients who have received at least first-line immunotherapy progression or intolerance in the past, and the number of previous systemic treatment lines does not exceed 2 lines; The best curative effect of frontline...
- 5) According to the evaluation criteria for the how well it works of solid tumors (RECIST 1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located...
- 6) The major organs function normally and meet the following criteria
- a. In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) ≥1.5x109 /L;
- b. Platelets ≥100×109 /L in the past 14 days without blood transfusion;
- c. Hemoglobin \>90g/L in the last 14 days without blood transfusion or use of erythropoietin;
- d. Total bilirubin ≤1.5× upper limit of normal (ULN);
- e. aspartate aminotransferase (AST), alanine aminotransferase (ALT) in ≤2.5×ULN (ALT or AST ≤5×ULN for patients with liver metastasis);
- f. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥40 ml/min;
- g. Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
- h. The myocardial enzyme profile is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality is not clinically significant, it is also allowed to be included);
- 7) Expected survival ≥3 months;
- 8) Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test...
- 9) Sign informed consent.
What rules you out
- 1) Patients who have previously received paclitaxel chemotherapy; Patients with neoadjuvant or adjuvant treatment with taxoid drugs and disease progression more than 6 months after the last chemotherapy were excluded;
- 2) HER2-positive patients;
- 3) Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose \>10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks before enrollment;
- 4) Patients with severe liver and kidney insufficiency or heart insufficiency;
- 5) have multiple factors that affect oral drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea, and intestinal obstruction);
- 6) Patients with brain metastases accompanied by symptoms or symptom control for less than 3 months;
- 7) Patients who are known to be allergic to any investigational drug or drug excipient;
- 8) Pregnant or lactating female patients;
- 9) Patients who underwent major surgical procedures (craniotomy, thoracotomy, or laparotomy) or had unhealed surgical wounds, ulcers, or fractures within 4 weeks prior to initial dosing, except for patients ≥2 weeks...
- 10) Patients with moderate to severe ascites accompanied by clinical symptoms requiring repeated drainage; Patients with uncontrolled or clinical symptoms of pleural effusion or pericardial effusion;
- 11) Patients with clinically significant electrolyte disorders;
- 12) People with acute or chronic active hepatitis B or hepatitis C: hepatitis B virus (HBV) DNA \> 2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA \> 103 copies /ml; Hepatitis B surface antigen (HbsAg) and...
- 13) Patients with central nervous system metastasis, but with no clinical symptoms or accompanied by clinical symptoms after treatment, disease control and stable time ≥4 weeks can be enrolled; To meet the need for...
- 14) Any life-threatening bleeding event within the previous 3 months, including patients requiring transfusion therapy, surgery or local therapy, and ongoing medication;
- 15) Patients with a history of arteriovenous thromboembolism events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein...
- 16) Uncontrolled hypertension, systolic blood pressure \> 160 MMHG or diastolic blood pressure \> 100mmHg after optimal medical treatment, hypertensive crisis or hypertensive encephalopathy history;
- 17) Symptomatic congestive heart failure (New York Heart Association Grade II-IV). Symptomatic or poorly controlled arrhythmia. Patients with a history of congenital long QT syndrome or a QTc \> 500ms (calculated using...
- 18) For patients who received radiation therapy more than 4 weeks before the first treatment, all of the following conditions must be met to be enrolled: there is no current toxic reaction related to radiation therapy...
- 19) Patients with previous or current pulmonary diseases such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and severe impairment of lung function;
- 20) Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), known syphilis infection;
- 21) Patients with unhealed wounds, fractures, gastric and duodenal ulcers, persistent positive stool occultiblood, ulcerative colitis, or other conditions that researchers have determined may cause gastrointestinal...
- 22) All adverse events during the screening period have not returned to baseline or ≤ Grade 1 (NCI-CTCAE V5.0) (except for alopecia, or peripheral sensory neuropathy, which can be grade 2);
- 23) Patients with severe infections that are active or poorly controlled clinically. Patients with severe infections in the 4 weeks prior to initial dosing, including but not limited to hospitalization for complications...
- 24) Use of immunosuppressive drugs within 4 weeks prior to initial administration, excluding nasal, inhaled, or other routes of topical corticosteroids or physiological doses of systemic corticosteroids (i.e., no more...
- 25) Patients who received live attenuated vaccine within 4 weeks prior to initial administration or who planned to receive live attenuated vaccine during the study period;
- 26) Patients who received major surgical treatment or significant traumatic injury 4 weeks prior to initial dosing
- 27) Patients who received traditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first dose;
- 28) Patients with a history of gastrointestinal perforation or abscess within 6 months prior to enrollment;
- 29) Received treatment in other clinical trials within 4 weeks prior to initial dosing;
- 30) Patients whose urine routine indicated urinary protein ≥2+, or 24-hour urinary protein quantity \>1.0g;
- 31) The presence of any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis); Patients with asthma...
- 32) Other acute or chronic medical conditions, psychiatric disorders, or abnormalities in laboratory test values that may contribute to these results: increase the risk associated with study participation or study drug...
- 33) Other situations deemed unsuitable for inclusion by the researcher.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.