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 range18 Years – 75 Years
SexALL
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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:
✓. 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.
✕
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
. 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).