Clinical trial for Gastric Cancer
Official title Low-dose Radiotherapy Combined With Chemotherapy and AK112 as Second-line Treatment in Patients With Advanced G/GEJ Cancer
ClinicalTrials.gov ID: NCT06791148
What this study is testing
What is albumin-bound paclitaxel?
albumin-bound paclitaxel is an investigational medicine, being studied as a potential treatment for gastric cancer.
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
- The study aims to evaluate the efficacy and safety of the combination of albumin-bound paclitaxel and AK112 with low-dose radiotherapy in patients with gastric adenocarcinoma and gastroesophageal junction adenocarcinoma who have failed first-line standard therapy.
- 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
- Sign the informed consent form.
- ≥18 years and ≤75 years .
- Histologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (AJCC 8.0);failed first-line...
- PS 0-2.
- Expected survival ≥ 6 months.
You likely can't join if
- Diagnosis of any malignancy other than gastric cancer within 5 years before the first dose (excluding cured basal cell or squamous cell skin cancers...
- Imaging during screening shows tumors encasing major blood vessels or with significant necrosis/cavitation, posing a bleeding risk as determined by...
- Currently participating in another treatment clinical study or received other investigational drugs or devices within 4 weeks before the first dose.
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before...
- Receiving systemic corticosteroid therapy (excluding nasal, inhaled, or other topical routes) or any other form of immunosuppressive therapy within 7...
- Known history of allogeneic organ transplantation (excluding corneal transplants) or allogeneic hematopoietic stem cell transplantation.
See the full eligibility criteria
- Sign the informed consent form.
- ≥18 years and ≤75 years .
- Histologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (AJCC 8.0);failed first-line standard treatment.
- PS 0-2.
- Expected survival ≥ 6 months.
- With at least one measurable lesion (RECIST 1.1 criteria) in the subject .
- Within 7 days before starting study treatment, no blood components or growth factors have been used, and Adequate organ function is determined by the following criteria: Absolute Neutrophil Count (ANC) ≥ 1.5 x...
- For women of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days before the first dose of study drug. If the urine test is inconclusive, a blood pregnancy test is required...
- All participants with fertility potential must use contraception with a failure rate \<1% during treatment and for 120 days after the last dose of study drug (or 180 days after the last chemotherapy dose), regardless of...
- Diagnosis of any malignancy other than gastric cancer within 5 years before the first dose (excluding cured basal cell or squamous cell skin cancers and/or carcinoma in situ treated with curative intent).
- Imaging during screening shows tumors encasing major blood vessels or with significant necrosis/cavitation, posing a bleeding risk as determined by the investigator.
- Currently participating in another treatment clinical study or received other investigational drugs or devices within 4 weeks before the first dose.
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose. Replacement therapies (e.g., thyroid hormone, insulin...
- Receiving systemic corticosteroid therapy (excluding nasal, inhaled, or other topical routes) or any other form of immunosuppressive therapy within 7 days before the first dose of the study.
- Known history of allogeneic organ transplantation (excluding corneal transplants) or allogeneic hematopoietic stem cell transplantation.
- Known allergy to any drug used in this study.
- Not fully recovered from toxicity and/or complications of any prior interventions before starting treatment (i.e., ≤ Grade 1 or returned to baseline, excluding fatigue or alopecia).
- Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies).
- Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA levels above the upper limit of normal at the study center).
- Active HCV infection (HCV antibody positive with HCV-RNA levels above the lower limit of detection).
- Received live vaccines within 30 days before the first dose (Day 1, Cycle 1). Note: Inactivated seasonal influenza vaccines administered by injection are allowed within 30 days before the first dose; however, intranasal...
- Pregnant or breastfeeding women.
- Presence of any severe or uncontrolled systemic diseases, including:
- Significant and symptomatic ECG abnormalities at rest that are difficult to control, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation.
- Unstable angina, congestive heart failure, or chronic heart failure classified as NYHA ≥ Grade 2.
- Any arterial thrombosis, embolism, or ischemia within 6 months before enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
- Suboptimal blood pressure control (systolic BP \> 150 mmHg, diastolic BP \> 100 mmHg).
- History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year before the first dose, or current clinically active interstitial lung disease.
- Active tuberculosis.
- Any active or uncontrolled infection requiring systemic treatment.
- Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
- Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis.
- Poorly controlled diabetes (fasting blood glucose \> 10 mmol/L).
- Any condition, illness, treatment, or abnormal laboratory value that could interfere with trial results, hinder the participant's full involvement in the study, or pose additional risks, as determined by the...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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 Nanjing, Jiangsu, 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.