Actively Recruiting
Carilizumab and Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer
Led by Shandong Tumor Hospital · Updated on 2026-03-13
40
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was an open, single center, prospective cohort study design. Subjects with advanced gastric cancer who had received first-line chemotherapy (cohort 1) and systematic chemotherapy combined with immunotherapy (cohort 2) were included in this study. 20 cases were included in each population, and a total of 40 subjects were planned to be included.
CONDITIONS
Official Title
Carilizumab and Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Diagnosed with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma by histology or cytology
- Previously received first-line systemic chemotherapy or chemotherapy combined with immunotherapy for disease progression
- For chemotherapy plus immunotherapy group, best response to first-line immunotherapy must be CR, PR, or SD for at least 3 months
- At least one measurable lesion not treated locally or progressing within previously irradiated areas
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate main organ functions and laboratory values meeting specified blood, liver, and kidney criteria
- Use of medically approved contraception during treatment and for 6 months after last dose
- HER2 negative status
- Voluntary informed consent, good compliance, and cooperation for follow-up
You will not qualify if you...
- History of gastrointestinal perforation or fistula within 6 months before first medication
- Uncontrollable pleural, pericardial, or peritoneal effusions requiring repeated drainage
- Allergies to monoclonal antibodies or components of study drugs
- Serious adverse reactions to prior immunotherapy making further use unsuitable
- Use of other investigational drugs within 4 weeks or half-life not passed
- Concurrent enrollment in other interventional clinical studies (except observational or follow-up)
- Anti-tumor therapy within 2 weeks before study drug
- Need for corticosteroids above 10mg prednisone daily within 2 weeks before study drug (with exceptions)
- Anti-tumor or live vaccines within 4 weeks before study drug
- Major surgery or severe trauma within 4 weeks before study drug
- Previous treatment with paclitaxel drugs
- Unresolved toxicity from prior anti-tumor treatments above grade 1 CTCAE (except hair loss)
- Presence of central nervous system metastases
- Active or history of autoimmune diseases (with specified exceptions)
- History of immune deficiency or positive HIV test, organ transplant, or active hepatitis
- Uncontrolled cardiovascular symptoms or diseases
- Severe infection within 4 weeks before study drug or active pulmonary inflammation within 2 weeks
- History of interstitial lung disease excluding specified exceptions
- Active or recent pulmonary tuberculosis infection
- Diagnosis of other malignant tumors within 5 years except low-risk types
- Pregnant or breastfeeding women
- Other serious illnesses or conditions that may affect safety or data collection as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shandong First Medical University Affiliated Cancer Hospital
Jinan, Shandong, China, 250021
Actively Recruiting
Research Team
Z
Zuoxing Niu, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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