New drug cocktail shows promise against tough esophageal cancer
NCT ID NCT07533305
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new combination of drugs (QL1706 plus chemotherapy) as the first treatment for people with advanced or spreading esophageal cancer. About 50 adults who have not had prior treatment will receive the combo to see if it shrinks tumors and how long it keeps the cancer from growing. The goal is to control the disease, not cure it.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects participate voluntarily and sign informed consent. * 18-75 years, male or female. * Histologically confirmed Unresectable Advanced or metastatic Esophageal Squamous Cell Carcinomas * No previous systemic anti-tumor treatment for unresectable locally advanced or metastatic esophageal squamous cell carcinoma has been received * At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1). * ECOG PS 0-1 * Expected survival ≥ 12 weeks * Adequate organ function (without blood transfusion or growth factors within 14 days prior to first dose), including: ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Total bilirubin ≤ 1.5 × ULN; ALT/AST ≤ 2.5 × ULN (≤ 5 × ULN if with liver or bone metastases); ALP ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN; INR ≤ 1.5 (if not on anticoagulation); * Non-sterilized women of childbearing potential and male participants with such partners must agree to use medically approved contraception during and for 3 months after study drug administration. Women must test negative for serum or urine HCG within 7 days prior to first dose and not be breastfeeding Exclusion Criteria: * Have received anti-PD-1 or anti-PD-L1 antibody therapy; * BMI \< 18.5 kg/m2 or weight loss ≥ 10% within 2 months before screening (at the same time, the effect of a large amount of pleural effusions and ascites on bogy weight should be considered); * Presence of any active autoimmune disease or history of autoimmune disease (such as: Autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism) * Those who are taking immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (dose\> 10 mg/day prednisone or other equivalent cortiremonial hormones) * Severe allergic reaction to other monoclonal antibodies * Known history or evidence of interstitial lung disease or active non-infectious pneumonia * Known central nervous system metastases * History of other malignancies within the past 5 years or concurrent malignancies (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix). * Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA class II or higher heart failure (2) unstable angina (3) myocardial infarction within the past year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) QTc \> 450 ms (male); QTc \> 470 ms (female) * Tumor invasion of major blood vessels, or based on imaging, the investigator determines a high likelihood of tumor invasion of major blood vessels during the study period, which may lead to fatal bleeding, such as imaging evidence of \>90-degree encasement of major vessels or tumor cavitation * Patients with pleural effusion, ascites, or pericardial effusion requiring drainage; if the symptoms are stable after drainage as assessed by the investigator, enrollment is possible. Gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the start of study treatment. * Major surgical procedures within 4 weeks prior to the start of study treatment (diagnostic procedures excluded) or anticipated need for major surgery during the study period. * Active infection, unexplained fever ≥38.5°C within 7 days prior to drug administration, or baseline white blood cell count \>15×109/L. * Congenital or acquired immunodeficiency (e.g., HIV infection); hepatitis B surface antigen (HBsAg) positive with hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥2000 IU/ml, or positive for hepatitis C virus antibody. * Live vaccine administration within 4 weeks prior to study drug administration or during the study period. * As judged by the investigator, other factors that may affect study outcomes or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases (including psychiatric disorders) requiring concurrent treatment, significant laboratory abnormalities, or family or social factors that may impact patient safety.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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