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

NCT ID: NCT05896787

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2026-08-01

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.

Detailed Description

Eligible patients first receive AK104 (10mg/kg, iv, Q2W) for one cycle in the induction period, and then patients receive AK104 (10mg/kg, iv, Q3W) combined with nab-paclitaxel (130mg/m2 ivgtt d1，d8, Q3W) and carboplatin ((AUC=5) d1，Q3W) for 2 cycles. After neoadjuvant therapy of 3 cycles, patient will undergo preoperative evaluation. For patients who can be performed for R0 surgery, surgery wil be performed in 4 to 6 weeks. Patients who do not achieve Pathological complete response (pCR) will receive AK104 (10mg/kg, iv, Q3W) as adjuvant therapy until disease progression or intolerable toxicity for up to 12 months. Patients who achieve pCR after surgery will be enrolled in observational follow-up.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK104 plus nab-paclitaxel and carboplatin

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.

Group Type: EXPERIMENTAL

AK104, nab-paclitaxel, carboplatin

Intervention Type: DRUG

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

Interventions

AK104, nab-paclitaxel, carboplatin

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

Intervention Type: DRUG

Other Intervention Names

Candonilimab，Preoperative Chemotherapy

Eligibility Criteria

Inclusion Criteria

1. Voluntarily signing a written informed consent form;

2. Males or females aged ≥ 18 to ≤ 70 years;

3. ECOG score 0-1;

4. Pathologically diagnosed thoracic esophageal squamous cell carcinoma;

5. 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);

6. Not received prior antitumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, etc. for esophageal cancer);

7. Life expectancy is greater than 6 months;

8. At least one measurable tumor lesion per RECIST v1.1;

9. Major organ functions are adequate;

Exclusion Criteria

1. Patient has received previous antitumor therapy (chemotherapy, radiation, surgery or immunotherapy);

2. Cervical or thoracic esophageal cancer is < 5 cm from the cricopharyngeal muscle;

3. Patients are or are expected to be at significant risk of esophageal perforation, fistula, and major bleeding;

4. 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;

5. 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)；

6. Pregnant or nursing women；

7. Patients with known or suspected active autoimmune disease;

8. Patients with a history of myocarditis, cardiomyopathy, malignant arrhythmias;

9. Other patients are not eligible for enrollment assessed by investigators;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: lead

Responsible Party

Feng Wang

Medical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng Wang

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Locations

Anyang Cancer Hospital

Anyang, Henan, China

Feng Wang

Zhengzhou, Henan, China

Countries

China

Central Contacts

Feng Wang

Role: CONTACT

fengw010@163.com

13938244776

Facility Contacts

Anlin Hao

Role: primary

Feng Wang

Role: primary

Other Identifiers

L2023-K003-002

Identifier Type: -

Identifier Source: org_study_id