Morning or afternoon? timing of immunotherapy infusion may affect esophageal cancer outcomes
NCT ID NCT07452601
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether giving immunotherapy (adebrelimab) plus chemotherapy at different times of day changes how well it works for people with esophageal cancer. 90 participants will be split into three groups based on infusion timing before surgery. The main goal is to see if timing affects the chance of a complete tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Adebrelimab plus nab-paclitaxel and cisplatin
- What this could lead to
- If timing matters, this could improve how well immunotherapy works for esophageal cancer, potentially leading to better tumor shrinkage before surgery.
- What could go wrong
- This is a small, early-phase study (90 people) focused on timing, not a new drug. Results may not change practice, and the combination has typical chemo side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2028
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: 1. Patients who have signed a written informed consent form and voluntarily agree to participate in the study. 2. Histologically or cytologically confirmed esophageal squamous cell carcinoma. 3. Tumor located in the thoracic esophagus, assessed by CT, MRI, EUS, or other imaging modalities, with clinical stage T1b-4aN+M0 or T2-4N0M0 (T2N0 patients must have high-risk features: lymphovascular invasion \[LVI\], tumor ≥3 cm, or poor differentiation) according to AJCC 8th edition. 4. Tumors deemed potentially resectable with R0 margins. 5. Age between 18 and 75 years, male or female. 6. ECOG performance status of 0 or 1. 7. No prior anti-tumor treatment for esophageal cancer, including surgery, radiotherapy, or chemotherapy. 8. Planned to undergo surgery after completion of neoadjuvant therapy. 9. No contraindications to surgery. 10. Adequate organ function, including: 1. Hematologic parameters(no blood products, growth factors, erythropoiesis-stimulating agents, or platelet-stimulating drugs within 14 days prior to first study drug administration): Absolute neutrophil count ≥1.5 × 10⁹/L;Platelet count ≥100 × 10⁹/L;Hemoglobin ≥90 g/L. 2. Biochemical parameters:Total bilirubin ≤1.5 × ULN; ALT ≤2.5 × ULN, AST ≤2.5 × ULN;Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min. 3. Coagulation parameters:International normalized ratio (INR) ≤1.5 × ULN; Activated partial thromboplastin time (APTT) ≤1.5 × ULN. 11. For women of childbearing potential, a negative serum pregnancy test within 72 hours prior to first study drug administration and agreement to use effective contraception during the study and for at least 3 months after the last dose (e.g., intrauterine device, oral contraceptives, or condoms). Male participants with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during the study and for at least 3 months after the last dose. 12. Good compliance and willingness to adhere to study procedures and follow-up. --- Exclusion Criteria: 1. Tumor with obvious invasion of adjacent critical structures, such as the aorta or trachea. 2. Presence of supraclavicular lymph node metastasis. 3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 4. Poor nutritional status with body mass index (BMI) \<18.5 kg/m²; patients whose nutritional status is corrected before randomization through supportive care may be considered eligible at the discretion of the principal investigator. 5. Known hypersensitivity to monoclonal antibodies, adebrelimab, nab-paclitaxel, cisplatin, or other platinum-based agents. 6. Prior or ongoing treatments as follows: 1. Any prior anti-tumor therapy, including chemotherapy, radiotherapy, or other anti-cancer drugs; 2. Use of systemic immunosuppressive therapy or corticosteroids for immunosuppression (\>10 mg/day prednisone or equivalent) within 2 weeks prior to first study drug administration. Inhaled or local steroid use and corticosteroid replacement therapy \>10 mg/day prednisone equivalent in patients without active autoimmune disease are permitted; 3. Administration of live attenuated vaccines within 4 weeks prior to first study drug administration; 4. Major surgery or severe trauma within 4 weeks prior to first study drug administration. 7. Active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (patients on stable hormone replacement therapy may be eligible). Patients with psoriasis or childhood asthma/allergy fully resolved in adulthood and not requiring intervention may be eligible, but those requiring ongoing medical management with bronchodilators are excluded. 8. History of immunodeficiency, including positive HIV test, other congenital or acquired immunodeficiency, or history of organ or allogeneic bone marrow transplantation. 9. Uncontrolled clinically significant cardiac conditions, including but not limited to: NYHA class II or higher heart failure;Unstable angina;Myocardial infarction within 1 year;Clinically significant supraventricular or ventricular arrhythmias inadequately controlled despite intervention. 10. Severe infection (CTCAE \> grade 2) within 4 weeks prior to first study drug administration requiring hospitalization, including severe pneumonia, bacteremia, or infectious complications. Patients with active pulmonary inflammation on baseline imaging, infection symptoms within 14 days prior to first study drug administration, or requiring oral/IV antibiotics (excluding prophylactic antibiotics) are excluded. 11. Active pulmonary tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or history of untreated active tuberculosis more than 1 year prior to enrollment. 12. Active hepatitis B (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL) or hepatitis C infection (positive HCV antibody with HCV RNA above the assay detection limit). 13. Diagnosis of other malignancies within the past 5 years, except for tumors with low risk of metastasis or mortality (5-year survival \>90%), such as adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ. 14. Pregnant or breastfeeding women. 15. Any other condition that, in the opinion of the investigator, could lead to premature discontinuation of study treatment or compromise participant safety or compliance, including serious comorbidities (including psychiatric disorders requiring concomitant therapy), alcohol or substance abuse, or social/familial factors.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Tangdu Hospital Affiliated to the Fourth Military Medical University
RECRUITINGXi'an, Shannxi, 710038, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Antibody-Drug conjugate targets advanced esophageal cancer after standard treatments fail
- Can a drug combo stop esophageal cancer from returning after surgery?
- Experimental drug put to the test against Hard-to-Treat GI cancers
- Can a drug combo shrink esophageal tumors before surgery?
- Two-Drug combo targets esophageal cancer that outsmarted immunotherapy
- Can a Triple-Drug combo shrink esophageal tumors before surgery?