LM-108 in Combination With Toripalimab Versus Paclitaxel Injection for the Treatment of Subjects … (NCT07362186) | Clinical Trial Compass
RecruitingPhase 3
LM-108 in Combination With Toripalimab Versus Paclitaxel Injection for the Treatment of Subjects With CCR8-Positive Gastric and Gastroesophageal Junction Adenocarcinoma
China400 participantsStarted 2026-04-30
Plain-language summary
This is a phase III， Multicenter, Randomized study， evaluating the efficacy and Safety of LM-108(an Anti-CCR8 mAb) in combination With Toripalimab Versus Paclitaxel Injection in subjects with CCR8-Positive locally advanced or metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma.
Who can participate
Age range
18 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
. Individuals who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
. Age 18 years or older, male or female.
. Weight ≥ 40 kg or Body Mass Index (BMI)≥ 18.5 kg/m²
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
. Life expectancy ≥ 3 months.
. Individuals must have histologically or cytologically confirmed locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma and be ineligible for curative surgery or radiotherapy.
. Confirmed CCR8-positive by the central laboratory.
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.
. HER2-negative, low-expressing, or non-expressing.
Exclusion criteria
. Received treatment targeting the same target or other drugs acting on regulatory T cells (Tregs).
. Received antitumor treatments such as chemotherapy, radiotherapy, biological therapy, immunotherapy, or Chinese herbal medicine or Chinese herbal preparations within 2-4 weeks (depending on the specific anticancer drug) prior to the first dose.
. Received anti-PD-(L)1 antibody immunotherapy and experienced disease progression confirmed by RECIST 1.1 assessment within ≤2 months after treatment initiation.
. Use of any live vaccine within 4 weeks prior to the first dosing of study drugs.
. Individuals who received major surgery or interventional treatment within 4 weeks prior to the first dosing of study drugs.
. Individuals who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of study drugs.
. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0, individuals who experienced ≥ Grade 3 immune-related adverse events during prior immunotherapy, or terminated prior immunotherapy due to severe or life-threatening immune-related adverse events.