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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853172
• Other study ID #: E20221047
• Status: Recruiting
• Phase: Phase 2
• Start date: March 21, 2023
• Est. completion date: December 21, 2025

Study information

• Verified date: April 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Han Liang, MD
• Phone: 18622221082
• Email: tjlianghan[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 21, 2025
• Est. primary completion date: March 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• AK104
Subjects will receive AK104 until disease progression or for up to 6 cycles.
• Apatinib
Subjects will receive apatinib until disease progression or for up to 6 cycles.
• Paclitaxel
Subjects will receive paclitaxel until disease progression or for up to 6 cycles.
• S-1
Subjects will receive S-1 until disease progression or for up to 6 cycles.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 surgical conversion rate		up to 2 years
Secondary	R0 resection rate		up to 2 years
Secondary	Pathological complete response (pCR)		up to 2 years
Secondary	Pathological major response (MPR)		up to 2 years
Secondary	Objective response rate (ORR)		up to 2 years
Secondary	Disease control rate (DCR)		up to 2 years
Secondary	Progression-free survival (PFS)		up to 2 years
Secondary	Adverse event (AE)		up to 2 years