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NOT YET RECRUITING
NCT07830355
PHASE2

Immunotherapy Plus Anlotinib After Surgery for Esophageal Squamous Cell Cancer With Residual Tumor and Positive Lymph Nodes

Sponsor: Shanghai Chest Hospital

View on ClinicalTrials.gov

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cycle * Continue treatment for up to 15 cycles unless the cancer returns, unacceptable side effects occur, consent is withdrawn, or another reason for stopping treatment arises * Undergo regular clinic visits, laboratory tests, physical examinations, and safety assessments during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.

Official title: A Single-Arm Study of Adjuvant Immunotherapy Plus Anlotinib in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma With Non-Major Pathological Response and ypN-Positive Disease After Neoadjuvant Chemoimmunotherapy and Surgery

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2026-09

Completion Date

2029-12

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

DRUG

Anlotinib

Anlotinib 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.

DRUG

Anti-PD-1 Monoclonal Antibody

An 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.