Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma

NCT05833971 | Not Yet Recruiting Phase 2

• 1 other identifier: Cadonilimab-Neoadjuvant
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm, multicenter, exploratory study to evaluate the efficacy and safety of AK104 in combination with cisplatin and paclitaxel in the treatment of resectable locally advanced esophageal squamous carcinoma.

Conditions

Resectable Esophageal Squamous Cell Carcinoma; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• pathologic complete response (pCR)

  Analysis of prognosis efficacy of patients: pathologic complete response (pCR)

  1 month after resection

Secondary Outcomes (5)

• Radical resection (R0)

  1 month after resection

• Overall survival(OS)

  up to 2 years

• Objective response rate(ORR)

  After the start of drugs and before resection

• Disease control rate(DCR)

  After the start of drugs and before resection

• Disease-free survival(DFS)

  After resection and up to 2 years

Study Arms (1)

Experimental: cadonilimab (AK104) + chemotherapy

EXPERIMENTAL

Drug: Cadonilimab+ chemotherapy，10mg/kg IV every 3 weeks (Q3W)，Other Name: AK104； Cisplatin，60-75mg/m2 IV every 3 weeks (Q3W)，Other Name: DDP；Albumin Paclitaxel，260mg/m2 IV every 3 weeks D1, 8(Q3W)，Other Name: Nab-PTX

Drug: cadonilimab+chemotherapy

Interventions

cadonilimab+chemotherapy DRUG

cadonilimab plus cisplatin and Nab-PTX, Q3W

Also known as: AK104

Experimental: cadonilimab (AK104) + chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years, both men and women
• Pathologically confirmed esophageal squamous cell carcinoma，and the clinic staging is cT2N1-3M0 or cT3N0-3M0 or cT4N0-3M0, TNM staging is II-IVA
• Non-cervical esophageal carcinoma
• Patients who have never received systemic antitumor therapy and who have measurable lesions that meet RECIST 1.1 criteria
• ECOG score 0-1
• Life expectancy ≥12 months
• Patients with normal function organs, no serious abnormalities of blood, heart, lung, liver, kidney function, and immunodeficiency disease
• For female subjects of childbearing age, they should have a negative urine or serum pregnancy test within 7 days before receiving the first study drug administration. Male and female patients need to use high-efficiency contraception during treatment until at least 8 weeks after stop the treatment
• Sign the informed consent form before any trial-related procedures are implemented

You may not qualify if:

• Other malignancies diagnosed within 5 years prior to the first administration of the study drug, except effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or effectively resected in situ cervical and/or breast cancer
• ulcerative esophageal squamous cell carcinoma
• Esophageal or tracheal fistula
• History of allergy to study drug components
• History of immune disease
• Patients with any serious or uncontrolled systemic disease
• The presence of any adverse event (CTCAE\>grade 1) caused by prior therapy

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: April 27, 2023
• Study Start: May 1, 2023
• Primary Completion: June 1, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share