Nab-paclitaxel Plus PD-1 Inhibitor Versus Nab-paclitaxel As Second-line Treatment in Advanced Gas… (NCT04294784) | Clinical Trial Compass
TerminatedPhase 2
Nab-paclitaxel Plus PD-1 Inhibitor Versus Nab-paclitaxel As Second-line Treatment in Advanced Gastric Cancer
Stopped: slow recruitment forcing early suspension of screening and enrollment
China58 participantsStarted 2020-04-03
Plain-language summary
This is a Multi-center, Open-label, Randomized Controlled,phase 2 clinical trail of Albumin-bound Paclitaxel Plus SHR-1210 （PD-1 inhibitor）Versus Albumin-bound Paclitaxel as Second-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
Who can participate
Age range
18 Years – 70 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
. Age of 18-70 years.
. Second line treatment for cytological or histological diagnosis of recurrent or metastatic gastric and esophagogastric adenocarcinoma. Disease progression after adjuvant therapy within 6 months is eligible.
. Left ventricular ejection fraction (LVEF) ≥ 50%.
. Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with hepatic metastases，total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome.
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
objective response rate(ORR)
Timeframe: up to 12 months
Trial details
NCT IDNCT04294784
SponsorHuazhong University of Science and Technology
. Any acute, clinically significant treatment-related toxicity caused by previous treatment must have been reduced to less than or equal to grade 1, except hair loss.
Exclusion criteria
. uncontrollable infections or have received systematic antibiotic treatment within 72 hours before enrollment.
. Any abnormal bone marrow hyperplasia or other abnormal hematopoietic function.
. Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer.
. Patients with symptomatic brain metastases.
. Allergic to the chemotherapy drugs or the materials in this study.
. Suffering from mental or nervous system disorders and unable to cooperate.
. Pregnant or nursing female patients. Men and women of reproductive age are unwilling to take reliable contraceptive measures during the study.
. Active autoimmune disease, history of autoimmune disease, use of corticosteroids or immunosuppressants, or use of hormone replacement therapy, such as thyroxine, insulin, etc.