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Immunomodulating Agents

Patients with locally advanced esophageal squamous cell carcinoma

cadonilimab (10mg/Kg, ivgtt, d1) and anlotinib (12mg, P.O., d1-d14) on a 21-day regimen for 3 cycles

Cadonilimab plus anlotinib

Fan Yang, M.D.

Xiang Yan, M.D.

The goal of this clinical trial is to learn if cadonilimab combined with anlotinib can be a safe and effective neoadjuvant therapy in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). The main questions it aims to answer are:

What level of pathological complete response (pCR) rate can be achieved with this neoadjuvant regimen? Is this neoadjuvant regimen safe enough with acceptable toxicity?

Participants will:

Receive cadonilimab (10mg/Kg, ivgtt, d1) and anlotinib (12mg, P.O., d1-d14) on a 21-day regimen for 3 cycles.

Undertake radical resection of ESCC after neoadjuvant therapy if there is no surgical contraindication.

Accept an follow-up for 2 years after surgery.

Esophageal cancer has a high incidence in China, among which esophageal squamous cell carcinoma is the most common. Neoadjuvant chemoradiotherapy combined with surgery is currently the recommended treatment modality for locally advanced esophageal cancer, but the side effects of chemoradiotherapy are serious, which increases the risk of surgery.

Immune checkpoint inhibitors have made significant progress in the field of cancer treatment in recent years, and have now become an important treatment method for advanced and metastatic esophageal cancer. Several trials on neoadjuvant immuno-chemotherapy demonstrated better outcomes with acceptable toxicity compared to traditional chemoradiotherapy. Cadonilimab is a dual immune antibody drug comprised of PD-1 antibody and CTLA-4 antibody, which has the anti-tumor effect of two immune checkpoint pathways at the same time.

On the other hand, angiogenesis plays a vital role in the growth and metastasis of tumors, and anti-angiogenic drugs have become an important part of cancer treatment. Anlotinib is an oral, small molecule anti-angiogenic targeted agent that has been approved for use in a variety of cancer treatments.

This study plans to conduct a prospective study of cadonilimab combined with anlotinib in the neoadjuvant treatment of resectable esophageal squamous cell carcinoma, and aims to explore the efficacy and safety of this neoadjuvant regimen that avoids chemoradiotherapy in locally advanced resectable esophageal squamous cell carcinoma.

Patients with locally advanced resectable esophageal squamous cell carcinoma

Neoadjuvant Cadonilimab Combined With Anlotinib in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Safety and Efficacy of Cadonilimab Combined With Anlotinib in Neoadjuvant Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: a Single Arm, Phase II Study

Pathological complete response (pCR) rate is defined as the percentage of participants with no residual viable tumor in primary tumor site or lymph nodes as evaluated by blinded independent pathological review (BIPR).

Major pathological response (MPR) rate is defined as the percentage of participants with less than or equal to 10% of residual viable tumor in primary tumor site or lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.

Objective response rate (ORR) is defined as the Percentage of participants achieving complete response (CR) or partial response (PR) in all patients with measurable disease at baseline, as assessed by the investigator according to RECIST version 1.1.

The incidence and severity of treatment emergent adverse events (including adverse events, serious adverse events and immune-related adverse events) among all participants.

EFS is defined as the time from participation to any of the following events: progression of disease, recurrence disease, or death due to any cause. Progression/recurrence will be assessed either by biopsy assessed by local pathologist or by investigator-assessed imaging using RECIST version 1.1.

Spots Global Cancer Trial Database for cadonilimab plus anlotinib