Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer

NCT ID: NCT05853172

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-21
• Study Completion Date: 2025-12-21

Brief Summary

This is a prospective, single-arm, open-label，single-center, phase II study, aiming to to evaluate the surgical conversion feasibility of AK104 combined with apatinib, paclitaxel and S-1 in unresectable stage IV G/GEJ cancer.

Detailed Description

Eligible patients receive AK104 (10mg/kg, iv, Q3W) combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis :90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycles. Patients assessed by Multi-Disciplinary Treatment (MDT) to meet the criteria for surgical resection undergo gastrectomy.

Conditions

Gastric Cancer

Study Design

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

Study Groups

AK104 plus apatinib, paclitaxel and S-1

AK104 (10mg/kg, iv, Q3W) is combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis: 90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycle for up to 6 cycles.

Group Type: EXPERIMENTAL

AK104

Intervention Type: DRUG

Subjects will receive AK104 until disease progression or for up to 6 cycles.

Apatinib

Intervention Type: DRUG

Subjects will receive apatinib until disease progression or for up to 6 cycles.

Paclitaxel

Intervention Type: DRUG

Subjects will receive paclitaxel until disease progression or for up to 6 cycles.

S-1

Intervention Type: DRUG

Subjects will receive S-1 until disease progression or for up to 6 cycles.

Interventions

AK104

Subjects will receive AK104 until disease progression or for up to 6 cycles.

Intervention Type: DRUG

Apatinib

Subjects will receive apatinib until disease progression or for up to 6 cycles.

Intervention Type: DRUG

Paclitaxel

Subjects will receive paclitaxel until disease progression or for up to 6 cycles.

Intervention Type: DRUG

S-1

Subjects will receive S-1 until disease progression or for up to 6 cycles.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.

2. Clinically diagnosed unresectable stage IV gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma by CT/MRI/Positron Emission Tomography (PET) -CT.

3. Not received prior systemic therapy for stage IV G/GEJ adenocarcinoma

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

5. Major organ functions are adequate;

6. Expected survival is ≥ 3 months;

7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1;

Exclusion Criteria

1. Human Epidermal GrowthFactor Receptor 2 (HER2)-positive G/GEJ adenocarcinoma;

2. Previously received immune checkpoint inhibitors, including but not limited to programmed death 1 (PD-1) inhibitors and cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors;

3. Central nervous system, lung, or bone metastases;

4. Known history of active or autoimmune disease;

5. Known history of other malignancies;

6. Known history of severe cardiovascular and cerebrovascular diseases;

7. Known history of gastrointestinal bleeding within the past 3 months or significant tendency to gastrointestinal bleeding;

8. Active infection or fever of unknown origin;

9. Known history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function;

10. Known history of immunodeficiency, positive HIV antibody (HIVAb) test, or other acquired or congenital immunodeficiency disorder, or active hepatitis;

11. Known history of mental disorder or psychoactive substance abuse;

12. Hypersensitivity to the drugs of this regimen;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Han Liang, MD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Han Liang, MD

Role: CONTACT

tjlianghan@126.com

18622221082

Facility Contacts

Han Liang, MD

Role: primary

tjlianghan@126.com

18622221082

Other Identifiers

E20221047

Identifier Type: -

Identifier Source: org_study_id