Actively Recruiting
Low-dose Radiotherapy Combined With Chemotherapy and AK112 as Second-line Treatment in Patients With Advanced G/GEJ Cancer
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2025-01-24
45
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low-dose Radiotherapy Combined With Chemotherapy and AK112 as Second-line Treatment in Patients With Advanced G/GEJ Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age between 18 and 75 years
- Histologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
- Failed first-line standard treatment
- Performance status (PS) of 0 to 2
- Expected survival of at least 6 months
- At least one measurable lesion according to RECIST 1.1 criteria
- No blood components or growth factors used within 7 days before treatment start
- Adequate organ function including neutrophils, platelets, hemoglobin, liver enzymes, kidney function, coagulation, and cardiac enzymes within specified limits
- For women of childbearing potential, negative pregnancy test within 3 days before first dose
- Use of effective contraception with failure rate less than 1% during treatment and for 120 days after last study drug dose (or 180 days after last chemotherapy dose) for all participants with fertility potential
You will not qualify if you...
- Diagnosis of any other malignancy within 5 years before first dose, except cured basal or squamous cell skin cancers and carcinoma in situ treated curatively
- Tumors encasing major blood vessels or with significant necrosis/cavitation posing bleeding risk
- Participation in another interventional clinical study or use of investigational drugs/devices within 4 weeks before first dose
- Active autoimmune disease requiring systemic treatment within 2 years before first dose
- Systemic corticosteroid or immunosuppressive therapy within 7 days before first dose
- History of allogeneic organ or hematopoietic stem cell transplantation (excluding corneal transplants)
- Known allergy to any study drug
- Not fully recovered from prior treatment toxicities or complications above grade 1 (excluding fatigue or alopecia)
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Receipt of live vaccines within 30 days before first dose (except inactivated seasonal influenza vaccine)
- Pregnant or breastfeeding women
- Severe or uncontrolled systemic diseases including significant ECG abnormalities, unstable angina, heart failure NYHA grade 2 or higher, recent arterial thrombosis or embolism, uncontrolled high blood pressure, history of pneumonitis requiring steroids, active interstitial lung disease, active tuberculosis, uncontrolled infections, diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, liver diseases like cirrhosis or hepatitis, poorly controlled diabetes
- Any other condition that may interfere with study participation or safety as determined by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
J
Jia Wei, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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