RecruitingPhase 2

Adebrelimab Neoadjuvant Treatment for Resectable ESCC: 2 vs 4 Cycles Study

China80 participantsStarted 2024-10-01

Plain-language summary

Observing the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as neoadjuvant treatment for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Written informed consent must be signed, and the participant must voluntarily join the study.
✓. Histologically or cytologically confirmed esophageal squamous cell carcinoma.
✓. Locally advanced thoracic esophageal cancer assessed by CT/MRI/EUS, with clinical staging T1b-4aN+M0 or T2-4N0M0 (T2N0 patients must have high-risk factors such as lymphovascular invasion \[LVI\], tumor size ≥3 cm, or poor differentiation) (according to AJCC 8th edition).
✓. Expected to achieve R0 resection.
✓. Age between 18 and 75 years, regardless of gender.
✓. ECOG Performance Status 0-1.
✓. No prior treatment for esophageal cancer, including radiotherapy, chemotherapy, or surgery.
✓. Planning to undergo surgery after completing neoadjuvant therapy.

Exclusion criteria

✕. Tumor clearly invading adjacent organs (e.g., major arteries or trachea).
✕. Supraclavicular lymph node metastasis.
✕. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
✕. Poor nutritional status, BMI \< 18.5 kg/m²; if corrected with symptomatic nutritional support before randomization, may be considered for inclusion after assessment by the principal investigator.
✕. History of allergy to monoclonal antibodies, Adebrelimab or its components, paclitaxel, cisplatin, or other platinum-based drugs.
✕. Previous or current treatment with:
✕. Active autoimmune diseases or a history of autoimmune diseases, including but not limited to: interstitial pneumonia, colitis, hepatitis, pituitaryitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered if on hormone replacement therapy); psoriasis or childhood asthma/allergy in complete remission without intervention can be considered, but those requiring bronchodilators for medical intervention cannot be included.
✕. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiencies, or history of organ transplantation or allogeneic bone marrow transplantation.

What they're measuring

Pathological complete response rate(pCR)

Timeframe: 7 days after surgery

Trial details

NCT IDNCT06663059

SponsorTang-Du Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

Contact for this trial

Tao Jiang, Dr

13572592311 jiangtaochest@163.com

View on ClinicalTrials.gov More Esophageal Cancer trials