Candonilimab (AK104) Plus Preoperative Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)

NCT05896787 | Not Yet Recruiting Phase 2

• 1 other identifier: L2023-K003-002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, single-arm, open-label，multi-center, phase II study, aiming to evaluate the efficacy and safety of AK104 combined with preoperative chemotherapy in patients with locally advanced ESCC.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

AK104; preoperative chemotherapy; surgery

Outcome Measures

Primary Outcomes (1)

• pCR

  Pathological complete response

  up to 2 years

Secondary Outcomes (6)

• MPR

  up to 2 years

• R0 resection rate

  up to 2 years

• Downstaging rate

  up to 2 years

• DFS

  up to 2 years

• OS

  up to 2 years

Study Arms (1)

AK104 plus nab-paclitaxel and carboplatin

EXPERIMENTAL

In the induction period, AK104 (10mg/kg, iv, Q2W) is given for one cycle; and then AK104 (10mg/kg, iv, Q3W) is combined with nab-paclitaxel (130mg/m2 ivgtt d1，d8, Q3W) and carboplatin ((AUC=5) d1，Q3W) for 2 cycles; After R0 surgery, AK104 (10mg/kg, iv, Q3W) is given as adjuvant therapy for up to 12 months for those who do not achieve pCR.

Drug: AK104, nab-paclitaxel, carboplatin

Interventions

AK104, nab-paclitaxel, carboplatin DRUG

AK104 plus nab-paclitaxel and carboplatin as neoadjuvant therapy，and AK104 as adjuvant therapy for those who do not achieve pCR;

Also known as: Candonilimab，Preoperative Chemotherapy

AK104 plus nab-paclitaxel and carboplatin

Eligibility Criteria

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

You may qualify if:

• Voluntarily signing a written informed consent form;
• Males or females aged ≥ 18 to ≤ 70 years;
• ECOG score 0-1;
• Pathologically diagnosed thoracic esophageal squamous cell carcinoma;
• No distant metastasis after imaging examination, and esophageal cancer can be resected or potentially resectable with stage cT1b-cT2N+M0 or cT3-cT4a anyN M0 or cT2N0M0 high-risk (lymphovascular invasion or tumor ≥3 cm or hypo-differentiation) (AJCC 8th edition cTNM stage);
• Not received prior antitumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, etc. for esophageal cancer);
• Life expectancy is greater than 6 months;
• At least one measurable tumor lesion per RECIST v1.1;
• Major organ functions are adequate;

You may not qualify if:

• Patient has received previous antitumor therapy (chemotherapy, radiation, surgery or immunotherapy);
• Cervical or thoracic esophageal cancer is \< 5 cm from the cricopharyngeal muscle;
• Patients are or are expected to be at significant risk of esophageal perforation, fistula, and major bleeding;
• Imaging during the screening period showed that the tumor surrounded or invaded important blood vessels or organs (such as the heart and pericardium, trachea, aorta, superior vena cava, etc.) or there was obvious necrosis or cavity, and the investigator determined that entering the study would cause bleeding risk; participants at risk of developing oesophageal or oesophageal fistula;
• Patients with a history of other malignant diseases in the last 5 years，unless complete resolution or no additional treatment is required (exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervix, or breast carcinoma in situ)；
• Pregnant or nursing women；
• Patients with known or suspected active autoimmune disease;
• Patients with a history of myocarditis, cardiomyopathy, malignant arrhythmias;
• Other patients are not eligible for enrollment assessed by investigators;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (2)

Anyang Cancer Hospital

Anyang, Henan, 450052, China

Location

Feng Wang

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

130-nm albumin-bound paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Feng Wang

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Wang

CONTACT

13938244776; fengw010@163.com

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: Medical Oncology

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 9, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)