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

• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05853172
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 33.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: AK104; Drug: Apatinib; Drug: Paclitaxel; Drug: S-1	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Surgical Conversion of Candonilimab (AK104) Combined With Paclitaxel, S-1 and Apatinib for Unresectable Advanced Gastric(G)/Gastroesophageal Junction(GEJ) Cancer
• Actual Study Start Date: Mar 21, 2023
• Anticipated Primary Completion Date: Mar 21, 2025
• Anticipated Study Completion Date: Dec 21, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: AK104; Subjects will receive AK104 until disease progression or for up to 6 cycles.; Drug: Apatinib; Subjects will receive apatinib until disease progression or for up to 6 cycles.; Drug: Paclitaxel; Subjects will receive paclitaxel until disease progression or for up to 6 cycles.; Drug: S-1; Subjects will receive S-1 until disease progression or for up to 6 cycles.

Outcome Measures

Primary Outcome Measures

1. R0 surgical conversion rate [up to 2 years]

Secondary Outcome Measures

1. R0 resection rate [up to 2 years]

2. Pathological complete response (pCR) [up to 2 years]

3. Pathological major response (MPR) [up to 2 years]

4. Objective response rate (ORR) [up to 2 years]

5. Disease control rate (DCR) [up to 2 years]

6. Progression-free survival (PFS) [up to 2 years]

7. Adverse event (AE) [up to 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin Medical University Cancer Institute and Hospital	Tianjin		China

Sponsors and Collaborators

• Tianjin Medical University Cancer Institute and Hospital

Investigators

• Principal Investigator: Han Liang, MD, Tianjin Medical University Cancer Institute and Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tianjin Medical University Cancer Institute and Hospital
• ClinicalTrials.gov Identifier: NCT05853172
• Other Study ID Numbers: E20221047
• First Posted: May 10, 2023
• Last Update Posted: May 10, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stomach Neoplasms; Paclitaxel; Apatinib

Study Results

No Results Posted as of May 10, 2023