Actively Recruiting
A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma
Led by The First Affiliated Hospital of Xiamen University · Updated on 2024-05-29
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the initial efficacy and safety of paclitaxel for injection (albumin-bound) in combination with apatinib mesylate and adebrelimab in the treatment of locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma following the progression of previous immunotherapy.
CONDITIONS
Official Title
A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Histologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
- Previously treated with at least one line of immunotherapy with progression or intolerance, with no more than two prior systemic treatment lines
- At least one measurable lesion by RECIST 1.1 criteria not previously treated with local therapies like radiotherapy, or progression confirmed in previously irradiated lesions
- Adequate major organ function including specific blood counts and liver, kidney, and coagulation parameters within defined limits
- Expected survival of 3 months or longer
- Women of childbearing potential must agree to use contraception during and for 6 months after the study, have a negative pregnancy test, and not be breastfeeding; men must agree to use contraception during and for 6 months after the study
- Signed informed consent
You will not qualify if you...
- Previous paclitaxel chemotherapy, except if neoadjuvant or adjuvant taxoid treatment was given and progression occurred more than 6 months after last chemotherapy
- HER2-positive cancer
- Use of immunosuppressants or systemic corticosteroids (above 10 mg prednisone daily) within 2 weeks before enrollment
- Severe liver, kidney, or heart insufficiency
- Conditions affecting oral drug absorption, such as inability to swallow or gastrointestinal obstruction
- Symptomatic brain metastases or brain metastases controlled for less than 3 months
- Known allergy to study drugs or their ingredients
- Pregnant or breastfeeding women
- Recent major surgery or unhealed wounds within 4 weeks before dosing, except for certain healed fractures or surgeries older than 2 weeks
- Moderate to severe symptomatic ascites, pleural or pericardial effusion
- Clinically significant electrolyte imbalances
- Active hepatitis B or C infection above defined viral load thresholds
- Central nervous system metastases not controlled or stable for at least 4 weeks
- Life-threatening bleeding events within past 3 months
- History of serious thromboembolism events within past 6 months, except stable catheter-related thrombosis
- Uncontrolled hypertension or history of hypertensive crisis
- Symptomatic congestive heart failure or serious arrhythmias; prolonged QT interval
- Radiation therapy within 4 weeks with unresolved side effects
- Significant pulmonary diseases affecting lung function
- HIV or syphilis infection
- Unhealed wounds, ulcers, gastrointestinal bleeding risks
- Adverse events from screening not resolved to baseline or mild grade, except alopecia or mild neuropathy
- Active or recent severe infections
- Recent use of immunosuppressive drugs or live vaccines
- Recent major surgery, trauma, or use of anti-tumor traditional Chinese medicine
- History of gastrointestinal perforation or abscess within 6 months
- Participation in other clinical trials within 4 weeks
- Urinary protein abnormalities
- Active or history of autoimmune diseases except certain controlled conditions
- Other medical or psychiatric conditions that increase risk or interfere with study participation
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Fuzhou, Fujian, China
Actively Recruiting
Research Team
M
Mingquan Cai
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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