A Clinical Study of SHR-9839 as Monotherapy or in Combination With Chemotherapy Plus Adebrelimab … (NCT07751341) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Clinical Study of SHR-9839 as Monotherapy or in Combination With Chemotherapy Plus Adebrelimab Versus Chemotherapy Plus Adebrelimab in Patients With Advanced Esophageal Squamous Cell Carcinoma
China84 participantsStarted 2026-08
Plain-language summary
An open-label, multicenter, randomized, phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839(sc) as monotherapy or in combination with chemotherapy plus adebelimab in patients with advanced esophageal squamous cell carcinoma (ESCC).
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
. Capable of providing informed consent; has signed and dated the IRB/EC-approved informed consent form, and is willing and able to comply with scheduled study visits, examinations and all other protocol-specified procedures.
. Aged between 18 and 75 years inclusive at the time of informed consent signature, irrespective of gender.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Must provide a minimum of 11 formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks or unstained tumor slides.
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
ORR：Objective Response Rate
Timeframe: First administration to end of treatment visit about 1year
. Females of childbearing potential must agree to use adequate effective contraception from the date of informed consent, throughout study treatment, and for 9 months after the last dose of investigational product, and refrain from oocyte donation during this period (refer to subsequent section for detailed contraceptive requirements).
Exclusion criteria
. Uncontrolled or symptomatic active central nervous system (CNS) metastases without adequate prior treatment.
. History of another concurrent malignant tumor diagnosed within 3 years prior to the first study drug administration.
. Presence of uncontrolled tumor-related pain as assessed by the Investigator.
. Severe cardiovascular or cerebrovascular diseases.
. History of interstitial lung disease (ILD) including idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans organizing pneumonia), drug-induced pneumonitis, radiation pneumonitis requiring steroid therapy; or suspected/unruled-out ILD on screening imaging; or moderate-to-severe pulmonary disease severely impairing respiratory function.
. Severe infection within 4 weeks before study treatment initiation, including but not limited to bacteremia, severe pneumonia or other infectious complications requiring hospitalization; active CTCAE Grade ≥2 infection requiring systemic antibiotics within 2 weeks prior to first dose (subjects on prophylactic antibiotics e.g., for urinary tract infection prophylaxis are eligible).
. History of immunodeficiency including positive HIV serology; active hepatitis B (positive HBsAg at screening plus HBV-DNA ≥2500 copies/mL /500 IU/mL or above local laboratory cutoff); or active hepatitis C (positive anti-HCV plus detectable HCV RNA).
. Active pulmonary tuberculosis within 1 year before enrollment by medical history or imaging; or prior active pulmonary tuberculosis \>1 year ago without standardized anti-tuberculosis treatment.