Low-dose Radiotherapy Combined With Chemotherapy and AK112 as Second-line Treatment in Patients W… (NCT06791148) | Clinical Trial Compass
RecruitingPhase 2
Low-dose Radiotherapy Combined With Chemotherapy and AK112 as Second-line Treatment in Patients With Advanced G/GEJ Cancer
China45 participantsStarted 2024-07-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival (PFS)
Timeframe: up to 24 months
2
AE
Timeframe: up to 24 months after enrollment or study close
Trial details
NCT IDNCT06791148
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
. 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. Postmenopausal women are defined as those who have had no menses for at least 1 year or have undergone surgical sterilization or hysterectomy.
Exclusion criteria
. 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 interventional 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, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments.
. 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).