Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable ESCC

Launched by ZHIGANG LI · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a new treatment approach for patients with esophageal squamous cell carcinoma (ESCC), a type of cancer affecting the esophagus. Specifically, the trial will offer a "watch-and-wait" strategy to patients who show no signs of remaining cancer after receiving a combination of a medication called adebrelimab and chemoradiotherapy. This means that instead of undergoing surgery right away, these patients will be monitored closely to see how they respond over time. The main goal of the study is to determine the survival rate of participants two years after their initial treatment.

To be eligible for the trial, participants need to be adults aged 18 to 75 with confirmed ESCC that can potentially be removed through surgery. They should not have received prior cancer treatments, and their overall health must meet certain criteria. If someone decides to participate, they will be asked to sign an informed consent form, ensuring they understand the trial's purpose and procedures. Importantly, the trial is not yet recruiting participants, so those interested should keep an eye out for when it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects signed the informed consent and volunteered to participate in the study.
• • 2. Esophageal squamous cell carcinoma confirmed by histology or cytology.
• • 3. Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as cII-III (AJCC 8th).
• • 4. Expect to have R0 resection
• • 5. In age from 18 to 75.
• • 6. ECOG PS: 0\~1.
• • 7. Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.
• • 8. No contraindications to surgery.
• • 9. Has sufficient organ function including (1) Blood routine: NE≥1.5×109/L; PLT≥100×109/L; HGB≥90 g/L (2)Comprehensive Metabolic Panel: bilirubin≤ 1.5×ULN; ALT≤2.5×ULN; AST≤2.5×ULN; sCr≤1.5×ULN or CrCl≥50 mL/min（Cocheroft-Gault) (3) Coagulation function: INR≤1.5; APTT≤1.5×ULN
• • 10. Women of childbearing age must undergo a serological pregnancy test within 72 hrs before first administration. Women of childbearing age, or male subjects with childbearing age female partners, must take contraceptive measures from the first dose to three months after last administration.
• • 11. Good compliance, willing to comply with follow-up schedules.
• Exclusion Criteria:
• 1. Subjects have received or are receiving any of:
• • 1. anti-tumor interventions such as radiotherapy, chemotherapy, or other medications.
• • 2. immunosuppressants or systemic glucosteroids (prednisone equivalence\> 10mg/d) within 2 weeks before the first administration, inhaled or topical use of glucosteroids (prednisone equivalence\>10mg/d) is allowed if no known active autoimmune disease.
• • 3. live vaccine within 4 weeks before the first administration.
• • 4. major surgery or major injury within 4 weeks before the first administration.
• • 2. Cancer-related exclusion criteria
• • 1. other cancers instead of ESCC
• • 2. unresectable or metastatic ESCC
• • 3. not comply with cⅡ-Ⅲ（cT2N1-2M0 or cT3N0-2M0, AJCC 8th）
• • 4. Subjects with other malignant tumors within 5 years before the first administration, but subjects with cervical carcinoma in situ, skin basal cell carcinoma, skin squamous cell carcinoma, localized prostate cancer received radical surgery and ductal carcinoma in situ that have received radical treatment and do not need other treatment can be included)
• • 3. Other criteria
• • 1. Subjects have uncontrolled cardiovascular diseases, such as 1) heart failure ≥ NYHA class 2, 2) unstable angina 3) myocardial infarction within 1 year; 4) supraventricular or ventricular arrhythmia that needs treatment
• • 2. Subjects with any known active autoimmune disease
• • 3. Pregnant or breastfeeding female
• • 4. Presence of allergy or hypersensitivity to investigational medications
• • 5. HIV-positive or active hepatitis B (HBsAg positive and HBV-DNA ≥2000 IU/ml or ≥ 104 copies/mL) or active hepatitis C (HCV antibody positive) or active tuberculosis
• • 6. Investigators assessed there might be other factors that cause subjects to withdraw.