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cycle * Continue treatment for up to 15 cycles unless the cancer returns, unacceptable side effects occur, consent is withdrawn, or another reason for stopping treatment arises * Undergo regular clinic visits, laboratory tests, physical examinations, and safety assessments during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.
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.
Esophageal cancer with a pathological type other than squamous cell carcinoma.
Distant organ or distant lymph node metastasis identified by preoperative imaging, intraoperative exploration, or postoperative pathological examination, corresponding to M1 disease according to the American Joint Committee on Cancer staging system, Eighth Edition.
No prior neoadjuvant therapy, or prior neoadjuvant therapy other than chemotherapy combined with immunotherapy, including neoadjuvant chemotherapy alone or neoadjuvant chemoradiotherapy.
Use of an anti-PD-L1 antibody or another immune checkpoint inhibitor other than an anti-PD-1 antibody during neoadjuvant treatment.
Single group
Anlotinib
DrugAnlotinib will be administered orally at a starting dose of 12 mg once daily on Days 1-14 of each 21-day cycle. Treatment will begin concurrently with anti-PD-1 immunotherapy within 10 weeks after surgery and continue for up to 15 cycles unless disease recurrence, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion occurs. Dose interruptions and reductions to 10 mg and 8 mg once daily are permitted according to protocol-defined toxicity management criteria.
Anti-PD-1 Monoclonal Antibody
DrugAn anti-PD-1 monoclonal antibody will be administered by intravenous infusion on Day 1 of each 21-day cycle, generally using the same anti-PD-1 agent administered during neoadjuvant treatment. Treatment will begin within 10 weeks after surgery and continue for up to 15 cycles unless disease recurrence, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion occurs. Dose reduction is not permitted; treatment-related toxicity will be managed by treatment interruption or permanent discontinuation according to the protocol.
1-Year Disease-Free Survival Rate
The Kaplan-Meier estimated percentage of participants who are alive without local or regional recurrence, distant metastasis, or a second primary malignancy at 12 months after enrollment. Disease-free survival is measured from the date of enrollment to the first occurrence of disease recurrence, a second primary malignancy, or death from any cause, whichever occurs first.
Disease-Free Survival
Time from enrollment to the first documented local or regional recurrence, distant metastasis, second primary malignancy, or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last disease assessment.
Overall Survival
Time from enrollment to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive.
Patterns of Disease Recurrence
The number and percentage of participants experiencing local recurrence, regional lymph node recurrence, or distant metastasis, as determined by imaging and pathological examination when clinically indicated. A participant may be included in more than one recurrence category if recurrence occurs at multiple sites.
Percentage of Participants With Treatment-Related Adverse Events
The percentage of participants experiencing adverse events considered by the investigator to be related to anti-PD-1 immunotherapy, anlotinib, or their combination. Adverse events will be classified and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0. Grade 3 or higher treatment-related adverse events and adverse events of special interest will also be summarized.
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