Resectable Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2NCT05960955
Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Cadonilimab, AK117 and Oxaliplatin in people with Resectable Gastric or Gastroesophageal Junction Adenocarcinoma, run by Akeso at 1 site in China.
Trial summary
This trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Cadonilimab, AK117 and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2023to 30 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Be able and willing to provide written informed consent.
- 18 to 75 years old.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a histologically confirmed diagnosis of Gastric or Gastroesophageal Junction Adenocarcinoma(G/GEJ).
- Has Stage T3-4N+M0 G/GEJ (American Joint Committee on Cancer [AJCC])
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Has adequate organ function.
Who cannot join
- Are there suspected metastases or locally advanced, unresectable disease, regardless of disease stage.
- Is currently participating in a study of an investigational agent or using an investigational device.
- Has undergone major surgery within 30 days of Study Day 1.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Han Liang, MD contact
China1 site, 1 recruiting
- Recruiting
Tianjin Provincial Tumor Hospital
Tianjin
Han Liang, MD
About this study
Official title: Phase II Clinical Study of Cadonilimab Combination With Chemotherapy With or Without the Anti-CD47 Antibody AK117 Neoadjuvant/Adjuvant Therapy for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
This trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117 neoadjuvantin treatment of resectable Gastric or Gastroesophageal Junction Adenocarcinoma.
- Being tested
- Cadonilimab, AK117, Oxaliplatin, Tegafur-gimeracil-oteracil potassium, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CadonilimabDrug
IV infusion,Specified dose on specified days
AK117Drug
IV infusion,Specified dose on specified days
OxaliplatinDrug
IV infusion,Specified dose on specified days
Tegafur-gimeracil-oteracil potassiumDrug
Oral,Specified dose on specified days
DocetaxelDrug
IV infusion,Specified dose on specified days
5-FluorouracilDrug
IV infusion,Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1 cohort 1 | Experimental | Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles. Receives: Drug: Cadonilimab; Drug: Oxaliplatin; Drug: Tegafur-gimeracil-oteracil potassium |
| Part 1 cohort 2 | Experimental | Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles. Receives: Drug: Cadonilimab; Drug: AK117; Drug: Oxaliplatin; Drug: Tegafur-gimeracil-oteracil potassium |
| Part 2 cohort 1 | Experimental | Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles. Receives: Drug: Cadonilimab; Drug: Oxaliplatin; Drug: Docetaxel; Drug: 5-Fluorouracil |
| Part 2 cohort 2 | Experimental | Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles. Receives: Drug: Cadonilimab; Drug: AK117; Drug: Oxaliplatin; Drug: Docetaxel; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance
Measured: Up to approximately 2 years
Pathological complete response (pCR) rates
pCR is defined the 0% residual viable tumor cells in the primary tumor and sampled lymph nodes
Measured: Up to approximately 2 years
Secondary outcomes (9)
Major pathological response(MPR) rates
MPR is defined the ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes
Measured: Up to approximately 2 years
Tumor regression grade(TRG)
Measured: Up to approximately 2 years
R0 resection rate
Measured: Up to approximately 2 years
Tumor descending stage rate
Proportion of subjects whose tumor TNM stage decreased from baseline before surgery
Measured: Up to approximately 2 years
ORR
Measured: Up to approximately 2 years
EFS
Measured: Up to approximately 2 years
OS
Measured: Up to approximately 2 years
PK
Serum drug concentrations of cadonilimab and/or AK117 in individual subjects at different time points
Measured: Up to approximately 2 years
ADA
Number of subjects with detectable anti-drug antibodies (ADA).
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start13 Nov 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Gastric or Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by AkesoThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960955
- Sponsor's protocol ID
- AK104-219
- Status last verified
- Nov 2023
- First submitted
- 17 Jul 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Cadonilimab Combination With Chemotherapy With or Without the Anti-CD47 Antibody AK117 Neoadjuvant/Adjuvant Therapy for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05960955
- Acronym / sponsor ID
- AK104-219
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 27 Jul 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 trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117 neoadjuvantin treatment of resectable Gastric or Gastroesophageal Junction Adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 cohort 1 | Experimental | Drug: Cadonilimab, Drug: Oxaliplatin, Drug: Tegafur-gimeracil-oteracil potassiumSubjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles. |
| Part 1 cohort 2 | Experimental | Drug: Cadonilimab, Drug: AK117, Drug: Oxaliplatin, Drug: Tegafur-gimeracil-oteracil potassiumSubjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles. |
| Part 2 cohort 1 | Experimental | Drug: Cadonilimab, Drug: Oxaliplatin, Drug: Docetaxel, Drug: 5-FluorouracilSubjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles. |
| Part 2 cohort 2 | Experimental | Drug: Cadonilimab, Drug: AK117, Drug: Oxaliplatin, Drug: Docetaxel, Drug: 5-FluorouracilSubjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 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)
- Be able and willing to provide written informed consent.
- 18 to 75 years old.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a histologically confirmed diagnosis of Gastric or Gastroesophageal Junction Adenocarcinoma(G/GEJ).
- Has Stage T3-4N+M0 G/GEJ (American Joint Committee on Cancer [AJCC])
Key exclusion criteria (8 listed)
- Are there suspected metastases or locally advanced, unresectable disease, regardless of disease stage.
- Is currently participating in a study of an investigational agent or using an investigational device.
- Has undergone major surgery within 30 days of Study Day 1.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
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 |
|---|---|---|
| CadonilimabIV infusion,Specified dose on specified days | Drug | Part 1 cohort 1, Part 1 cohort 2, Part 2 cohort 1, Part 2 cohort 2 |
| AK117IV infusion,Specified dose on specified days | Drug | Part 1 cohort 2, Part 2 cohort 2 |
| OxaliplatinIV infusion,Specified dose on specified days | Drug | Part 1 cohort 1, Part 1 cohort 2, Part 2 cohort 1, Part 2 cohort 2 |
| Tegafur-gimeracil-oteracil potassiumOral,Specified dose on specified days | Drug | Part 1 cohort 1, Part 1 cohort 2 |
| DocetaxelIV infusion,Specified dose on specified days | Drug | Part 2 cohort 1, Part 2 cohort 2 |
| 5-FluorouracilIV infusion,Specified dose on specified days | Drug | Part 2 cohort 1, Part 2 cohort 2 |
Primary outcome
Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance
Time frame: Up to approximately 2 years
Pathological complete response (pCR) rates
Time frame: Up to approximately 2 years
pCR is defined the 0% residual viable tumor cells in the primary tumor and sampled lymph nodes
9 secondary outcomes
Major pathological response(MPR) rates
Time frame: Up to approximately 2 years
Tumor regression grade(TRG)
Time frame: Up to approximately 2 years
R0 resection rate
Time frame: Up to approximately 2 years
Tumor descending stage rate
Time frame: Up to approximately 2 years
ORR
Time frame: Up to approximately 2 years
EFS
Time frame: Up to approximately 2 years
OS
Time frame: Up to approximately 2 years
PK
Time frame: Up to approximately 2 years
ADA
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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.
Han Liang, MD contact
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 Cadonilimab, AK117 and Oxaliplatin in people with Resectable Gastric or Gastroesophageal Junction Adenocarcinoma, run by Akeso 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 8 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: looking for participants now, as of the sponsor's last update on 18 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weifeng Song, MD (+86(0760)89873999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. 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 18 Nov 2023.