Combining AK104 with chemotherapy for advanced gastric cancer

Surgical Conversion of Candonilimab (AK104) Combined With Paclitaxel, S-1 and Apatinib for Unresectable Advanced Gastric(G)/Gastroesophageal Junction(GEJ) Cancer

This study is testing if a combination of new and existing treatments can help people with advanced stomach cancer become healthy enough for surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: radiation, apatinib
• Locations: 1 site (Tianjin)
• Trial ID: NCT05853172 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the feasibility of surgical conversion in patients with unresectable stage IV gastric or gastroesophageal junction cancer using a combination of AK104, apatinib, paclitaxel, and S-1. Eligible participants will receive these treatments for up to six cycles, followed by assessment by a Multi-Disciplinary Treatment team to determine if they qualify for surgical resection. The study is conducted at a single center and aims to provide insights into the effectiveness of this combination therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with unresectable stage IV gastric or gastroesophageal junction adenocarcinoma who have not received prior systemic therapy.

Not a fit: Patients with HER2-positive tumors or those who have previously received immune checkpoint inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enable surgical options for patients with previously unresectable advanced gastric cancer.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches using targeted therapies and chemotherapy have shown promise in other studies.

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;

Where this trial is running

Tianjin

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, China (Recruiting)

Study contacts

• Principal investigator: Han Liang, MD — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Han Liang, MD

Conditions Gastric Cancer