A Phase II Study of Carelizumab Combined With Irinotecan and Apatinib of Second-line Treatment fo… (NCT04934618) | Clinical Trial Compass
UnknownPhase 2
A Phase II Study of Carelizumab Combined With Irinotecan and Apatinib of Second-line Treatment for Advanced Gastric Cancer
China85 participantsStarted 2020-05-19
Plain-language summary
The purpose of this study was to evaluate the overall survival time (OS), objective remission rate（ORR）, progression-free survival time（PFS）, disease control rate（DCR）of Carelizumab combined with irinotecan and apatinib for the second-line treatment of locally advanced unresectable, recurrent or metastatic adenocarcinoma of stomach and gastroesophageal junction. At the same time, the safety and tolerance of the scheme were preliminarily evaluated.
Who can participate
Age range
18 Years – 75 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
. The local advanced stage confirmed by histopathology is unresectable, recurrent or metastatic Adenocarcinoma of stomach and gastroesophageal junction.
. After receiving first-line treatment, the disease progressed or intolerable adverse reactions occurred.
. At least one measurable lesion or evaluable lesion (according to RECIST 1.1 standard);
. Patients agreed to provide blood samples and previously stored tumor tissue samples for tumor microenvironment detection.
. Age ≥18 years old and ≤75 years old.
. The ECOG score is 0 or 1.
. The estimated survival time is ≥3 months.
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
Overall Suvival time（OS）
Timeframe: Up to 24 months
Trial details
NCT IDNCT04934618
SponsorNanfang Hospital, Southern Medical University
. Within 7 days before entering the group, the laboratory test value met the chemotherapy standard.
Exclusion criteria
. Participate in other intervention clinical studies at the same time (unless participating in observation studies or being in the follow-up stage of intervention studies), and have received second-line treatment.
. have received antibody therapy of PD-1, PD-L1, PD-L2, CTLA4, CD137 or any other antibody or drug therapy with t cell co-stimulation or immune checkpoint pathway as specific target.
. It is known to be allergic to any monoclonal antibody or adjuvant.
. Received Chinese patent medicines with anti-tumor indications or drugs with immunoregulatory effects (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration.
. Having undergone major surgery within 4 weeks before the first administration or expecting to undergo surgery during the study treatment.
. Receive live attenuated vaccine within 4 weeks before the first administration or during the planned study treatment.
. Received transplantation of solid organs or blood system.
. Active, known or suspected autoimmune diseases or related medical history in the past 2 years (vitiligo, psoriasis, alopecia or Graves' disease that does not require systematic treatment in the past 2 years, hypothyroidism that only requires thyroid hormone replacement therapy, and type I diabetes patients who only need insulin replacement therapy can enter Group).