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Trial Title:
Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer
NCT ID:
NCT05853172
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Paclitaxel
Apatinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK104
Description:
Subjects will receive AK104 until disease progression or for up to 6 cycles.
Arm group label:
AK104 plus apatinib, paclitaxel and S-1
Intervention type:
Drug
Intervention name:
Apatinib
Description:
Subjects will receive apatinib until disease progression or for up to 6 cycles.
Arm group label:
AK104 plus apatinib, paclitaxel and S-1
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Subjects will receive paclitaxel until disease progression or for up to 6 cycles.
Arm group label:
AK104 plus apatinib, paclitaxel and S-1
Intervention type:
Drug
Intervention name:
S-1
Description:
Subjects will receive S-1 until disease progression or for up to 6 cycles.
Arm group label:
AK104 plus apatinib, paclitaxel and S-1
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Han Liang, MD
Phone:
18622221082
Email:
tjlianghan@126.com
Investigator:
Last name:
Han Liang, MD
Email:
Principal Investigator
Start date:
March 21, 2023
Completion date:
December 21, 2025
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05853172
