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

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
AK104
Apatinib
Paclitaxel
S-1
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. Clinically diagnosed unresectable stage IV gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma by CT/MRI/Positron Emission Tomography (PET) -CT. Not received prior systemic therapy for stage IV G/GEJ adenocarcinoma At least one measurable tumor lesion per RECIST v1.1; Major organ functions are adequate; Expected survival is ≥ 3 months; Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1; Exclusion Criteria: Human Epidermal GrowthFactor Receptor 2 (HER2)-positive G/GEJ adenocarcinoma; 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; Central nervous system, lung, or bone metastases; Known history of active or autoimmune disease; Known history of other malignancies; Known history of severe cardiovascular and cerebrovascular diseases; Known history of gastrointestinal bleeding within the past 3 months or significant tendency to gastrointestinal bleeding; Active infection or fever of unknown origin; Known history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function; Known history of immunodeficiency, positive HIV antibody (HIVAb) test, or other acquired or congenital immunodeficiency disorder, or active hepatitis; Known history of mental disorder or psychoactive substance abuse; Hypersensitivity to the drugs of this regimen;

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AK104 plus apatinib, paclitaxel and S-1

Arm Description

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.

Outcomes

Primary Outcome Measures

R0 surgical conversion rate

Secondary Outcome Measures

R0 resection rate
Pathological complete response (pCR)
Pathological major response (MPR)
Objective response rate (ORR)
Disease control rate (DCR)
Progression-free survival (PFS)
Adverse event (AE)

Full Information

First Posted
April 24, 2023
Last Updated
May 7, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05853172
Brief Title
Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer
Official Title
Surgical Conversion of Candonilimab (AK104) Combined With Paclitaxel, S-1 and Apatinib for Unresectable Advanced Gastric(G)/Gastroesophageal Junction(GEJ) Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
March 21, 2025 (Anticipated)
Study Completion Date
December 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AK104 plus apatinib, paclitaxel and S-1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
AK104
Intervention Description
Subjects will receive AK104 until disease progression or for up to 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Subjects will receive apatinib until disease progression or for up to 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Subjects will receive paclitaxel until disease progression or for up to 6 cycles.
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
Subjects will receive S-1 until disease progression or for up to 6 cycles.
Primary Outcome Measure Information:
Title
R0 surgical conversion rate
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
R0 resection rate
Time Frame
up to 2 years
Title
Pathological complete response (pCR)
Time Frame
up to 2 years
Title
Pathological major response (MPR)
Time Frame
up to 2 years
Title
Objective response rate (ORR)
Time Frame
up to 2 years
Title
Disease control rate (DCR)
Time Frame
up to 2 years
Title
Progression-free survival (PFS)
Time Frame
up to 2 years
Title
Adverse event (AE)
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. Clinically diagnosed unresectable stage IV gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma by CT/MRI/Positron Emission Tomography (PET) -CT. Not received prior systemic therapy for stage IV G/GEJ adenocarcinoma At least one measurable tumor lesion per RECIST v1.1; Major organ functions are adequate; Expected survival is ≥ 3 months; Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1; Exclusion Criteria: Human Epidermal GrowthFactor Receptor 2 (HER2)-positive G/GEJ adenocarcinoma; 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; Central nervous system, lung, or bone metastases; Known history of active or autoimmune disease; Known history of other malignancies; Known history of severe cardiovascular and cerebrovascular diseases; Known history of gastrointestinal bleeding within the past 3 months or significant tendency to gastrointestinal bleeding; Active infection or fever of unknown origin; Known history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function; Known history of immunodeficiency, positive HIV antibody (HIVAb) test, or other acquired or congenital immunodeficiency disorder, or active hepatitis; Known history of mental disorder or psychoactive substance abuse; Hypersensitivity to the drugs of this regimen;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Han Liang, MD
Phone
18622221082
Email
tjlianghan@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Liang, MD
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Liang, MD
Phone
18622221082
Email
tjlianghan@126.com
First Name & Middle Initial & Last Name & Degree
Han Liang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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