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NCT07830355
Immunotherapy Plus Anlotinib After Surgery for Esophageal Squamous Cell Cancer With Residual Tumor and Positive Lymph Nodes
Conditions: Esophageal Squamous Cell Carcinoma
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 75
Sponsor: Shanghai Chest Hospital
Summary
The goal of this clinical trial is to learn whether postoperative immunotherapy combined with anlotinib can help prevent or delay cancer recurrence in adults aged 18 to 75 years with locally advanced esophageal squamous cell carcinoma. Eligible participants must have previously received chemotherapy combined with anti-PD-1 immunotherapy, followed by complete surgical removal of the cancer. Examination of the surgical specimens must show more than 10% viable tumor remaining in the original tumor bed and cancer cells remaining in regional lymph nodes.
The main questions this trial aims to answer are:
* What proportion of participants are alive without cancer recurrence or a second primary cancer 12 months after enrollment?
* How long do participants remain free of cancer recurrence, and how long do they survive?
* What treatment-related medical problems occur during treatment with anti-PD-1 immunotherapy plus anlotinib?
* Where does the cancer recur if recurrence occurs? All participants will receive the same study treatment; there is no comparison group.
Participants will:
* Receive an anti-PD-1 immunotherapy medicine by intravenous infusion once every 3 weeks, generally using the same anti-PD-1 medicine received before surgery
* Take anlotinib by mouth once daily for 14 days, followed by 7 days without anlotinib, in each 21-day treatment cycle
* Continue treatment for up to 15 cycles unless the cancer returns, unacceptable side effects occur, consent is withdrawn, or another reason for stopping treatment arises
* Undergo regular clinic visits, laboratory tests, physical examinations, and safety assessments during treatment
* Undergo imaging examinations approximately every 3 months to check for cancer recurrence
* Be followed for disease recurrence and survival for up to 5 years after surgery Stored surgical tumor tissue will also be studied to explore whether features of the tumor immune environment are associated with treatment outcomes.
Eligibility Criteria
Inclusion Criteria:
* Age 18 to 75 years, inclusive.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Histologically confirmed locally advanced esophageal squamous cell carcinoma.
* Prior treatment with 2 to 4 cycles of neoadjuvant chemotherapy combined with an anti-PD-1 monoclonal antibody, followed by radical surgery with pathologically confirmed R0 resection.
* An interval of no more than 10 weeks between completion of the last neoadjuvant chemotherapy or immunotherapy treatment and radical surgery.
* Postoperative pathological assessment showing non-major pathological response, defined as more than 10% residual viable tumor cells in the primary tumor bed, and viable tumor metastasis in at least one resected regional lymph node (ypN-positive disease).
* Enrollment within 10 weeks after esophagectomy.
* Ability to swallow and tolerate oral medication, without severe dysphagia, chronic diarrhea, intestinal obstruction, or another condition that may substantially affect oral drug absorption.
* Adequate organ function, based on laboratory tests performed within 7 days before the first dose and without blood transfusion, erythropoietin, granulocyte colony-stimulating factor, or similar supportive treatment within the preceding 14 days, meeting all of the following criteria:
* Absolute neutrophil count ≥1.5 × 10\^9/L.
* Platelet count ≥100 × 10\^9/L.
* Hemoglobin ≥90 g/L.
* Total bilirubin ≤1.5 × the upper limit of normal (ULN).
* Alanine aminotransferase and aspartate aminotransferase ≤2.5 × ULN.
* Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min.
* Urine protein negative or 1+ on routine urinalysis. If urine protein is 2+ or higher, 24-hour urinary protein must be ≤1.0 g.
* International normalized ratio ≤1.5, prothrombin time no more than 4 seconds above ULN, and activated partial thromboplastin time ≤1.5 × ULN.
* Systolic blood pressure \
Source: ClinicalTrials.gov (NCT07830355). StuddyBuddy aggregates publicly available trial information.