Gastric CancerPhase 2NCT05853172
Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer
A Phase 2 study testing AK104, Apatinib and Paclitaxel in people with Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- AK104, Apatinib and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2023to 21 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Han Liang, MD, 18622221082, tjlianghan@126.com
Han Liang, MD
About this study
Official title: Surgical Conversion of Candonilimab (AK104) Combined With Paclitaxel, S-1 and Apatinib for Unresectable Advanced Gastric(G)/Gastroesophageal Junction(GEJ) Cancer
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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- AK104, Apatinib, Paclitaxel, S-1
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104Drug
Subjects will receive AK104 until disease progression or for up to 6 cycles.
ApatinibDrug
Subjects will receive apatinib until disease progression or for up to 6 cycles.
PaclitaxelDrug
Subjects will receive paclitaxel until disease progression or for up to 6 cycles.
S-1Drug
Subjects will receive S-1 until disease progression or for up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| AK104 plus apatinib, paclitaxel and S-1 | Experimental | 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. Receives: Drug: AK104; Drug: Apatinib; Drug: Paclitaxel; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 surgical conversion rate
Measured: up to 2 years
Secondary outcomes (7)
R0 resection rate
Measured: up to 2 years
Pathological complete response (pCR)
Measured: up to 2 years
Pathological major response (MPR)
Measured: up to 2 years
Objective response rate (ORR)
Measured: up to 2 years
Disease control rate (DCR)
Measured: up to 2 years
Progression-free survival (PFS)
Measured: up to 2 years
Adverse event (AE)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start21 Mar 2023
- Primary completion21 Mar 2025 (estimated)
- Study completion21 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Han Liang, MD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853172
- Sponsor's protocol ID
- E20221047
- Status last verified
- Apr 2023
- First submitted
- 24 Apr 2023
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Conversion of Candonilimab (AK104) Combined With Paclitaxel, S-1 and Apatinib for Unresectable Advanced Gastric(G)/Gastroesophageal Junction(GEJ) Cancer
- ClinicalTrials.gov ID
- NCT05853172
- Acronym / sponsor ID
- E20221047
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 21 Mar 2025 (estimated)
- Study completion
- 21 Dec 2025 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK104 plus apatinib, paclitaxel and S-1 | Experimental | Drug: AK104, Drug: Apatinib, Drug: Paclitaxel, Drug: S-1AK104 (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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK104Subjects will receive AK104 until disease progression or for up to 6 cycles. | Drug | AK104 plus apatinib, paclitaxel and S-1 |
| ApatinibSubjects will receive apatinib until disease progression or for up to 6 cycles. | Drug | AK104 plus apatinib, paclitaxel and S-1 |
| PaclitaxelSubjects will receive paclitaxel until disease progression or for up to 6 cycles. | Drug | AK104 plus apatinib, paclitaxel and S-1 |
| S-1Subjects will receive S-1 until disease progression or for up to 6 cycles. | Drug | AK104 plus apatinib, paclitaxel and S-1 |
Primary outcome
R0 surgical conversion rate
Time frame: up to 2 years
7 secondary outcomes
R0 resection rate
Time frame: up to 2 years
Pathological complete response (pCR)
Time frame: up to 2 years
Pathological major response (MPR)
Time frame: up to 2 years
Objective response rate (ORR)
Time frame: up to 2 years
Disease control rate (DCR)
Time frame: up to 2 years
Progression-free survival (PFS)
Time frame: up to 2 years
Adverse event (AE)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han Liang, MD principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK104, Apatinib and Paclitaxel in people with Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han Liang, MD (18622221082, tjlianghan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 surgical conversion rate (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.