Gastric CancerPhase 2NCT05948449
To Evaluate the Efficacy and Safety of Cadonilimab With SOX as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
A Phase 2 study testing S-1, Oxaliplatin, Cadonilimab in people with Gastric Cancer, run by Sichuan University.
Trial summary
The Purpose of This Study is to Evaluate the Efficacy and Safety of Cadonilimab（AK104） in Combination With SOX as Neoadjuvant Therapy for Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma. 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?
- S-1, Oxaliplatin, Cadonilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Jul 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
- Age 18-75 years.
- Histologically or cytologically confirmed diagnosis of adenocarcinoma locate at gastroesophageal junction or stomach, advanced gastric or gastroesophageal junction cancer as assessed by ultrasonography and/or CT/MRI (cT3-T4a, N+, M0).
- Resectable gastric or gastroesophageal cancer, judged by surgeons in this study.
- No previous anti-tumor treatment.
- The expected survival is no less than 3 months.
- ECOG PS≤1.
Show all 18Show fewer
- Adequate organ function including the following:
- Total bilirubin ≤1.5 times upper limit of normal (ULN),
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3×ULN,
- Alkaline phosphatase≤2.5×ULN (If the tumor invaded the liver, ≤3×ULN),
- Serum creatinine≤1.5×ULN,
- Serum amylase and lipase≤1.5×ULN,
- International standardized ratio (INR)/partial prothrombin time (PTT)≤1.5×ULN;
- Platelet count ≥ 75,000 /mm3.
- Hemoglobin (Hb) ≥ 9 g/dL.
- Absolute neutrophil count (ANC) ≥ 1500/mm3.
- Strict contraception.
- Patients must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
Who cannot join
- Unable to comply with the research program or procedures.
- Undergoing other drug clinical trials, or has participated in any drug clinical trials one month before enrollment.
- Active autoimmune disease or history of refractory autoimmune disease.
- Receiving corticosteroid (> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting.
- Active or clinically significant cardiac disease:
- Congestive heart failure > New York Heart Association (NYHA ) class 2;
Show all 34Show fewer
- Active coronary artery disease;
- Arrhythmias requiring treatment other than β-blocker or digoxin;
- Unstable angina (with angina symptoms at rest), new angina within 3 months before enrollment, or new myocardial infarction within 6 months before enrollment
- Evidence or history of bleeding diathesis or coagulopathy.
- Grade 3 bleeding events 4 weeks before enrollment.
- Thromboembolism or arteriovenous events, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis or pulmonary embolism, occurred 6 months before enrollment.
- Currently taking anticoagulants.
- Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor has been cured and no evidence of disease has been found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment.
- Patients with pheochromocytoma.
- Patients with a history of HIV infection or active hepatitis B/C.
- Ongoing > level 2 infection.
- Symptomatic brain metastasis or meningioma.
- Unhealed wounds, ulcers or fractures.
- Renal failure patients requiring blood or peritoneal dialysis.
- Dehydration≥ 1 grade.
- Epileptic that need medication.
- Active, symptomatic interstitial pneumonia, pleural or ascites that causes dyspnea (dyspnea ≥ 2 grade).
- History of organ transplantation. (including corneal transplantation).
- Allergic to research drugs or similar drugs, or suspected allergies.
- Malabsorption patients.
- Pregnant or lactating women.
- Investigator believes that patients who are not suitable for the study.
- Medical, psychological or social conditions can affect the recruitment of patients and evaluation for study results.
- Other anti-tumor therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) other than investigator drugs. Palliative external irradiation for non-target lesions is allowed.
- Previously used oxaliplatin, S-1 or Cadonilimab.
- Major surgery 4 weeks before recruitment, open biopsy or major trauma surgery. (excluding biliary stents, or percutaneous biliary drainage).
- Treatment with anti-tumor Chinese herbal medicine.
- History of allogeneic blood transfusion within 6 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy and Safety of Chemotherapy Combined With Cadonilimab (AK104) in Neoadjuvant Treatment of Locally Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma: A Prospective, Single-arm, Phase II Clinical Study
The Purpose of This Study is to Evaluate the Efficacy and Safety of Cadonilimab（AK104） in Combination With SOX as Neoadjuvant Therapy for Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma.
Read the detailed description
Recent years, neoadjuvant therapy have emerged as a promising treatment option for the treatment of locally advanced gastric or gastroesophageal adenocarcinoma. However, the efficacy of current neoadjuvant regimens is still unsatisfactory. Novel treatment with higher efficacy and safety are urgently needed. Recently, immunotherapy has achieved significant therapeutic effects in the treatment of a series of cancers, and chemotherapy combined with immunotherapy has been recommended as the standard first-line treatment for gastric cancer. Moreover, several phase I/II studies have explored the efficacy and safety of chemotherapy combined with PD-1 inhibitor in the neoadjuvant treatment for gastric cancer, the results of which indicate that chemotherapy combined with immunotherapy can significantly improve the pCR rate and R0 resection rate of gastric cancer. In this study, we will evaluate the efficacy and safety of chemotherapy combined with Cadonilimab（AK104） (a PD-1/CTLA-4 bispecific antibody) in the neoadjuvant therapy for resectable locally advanced gastric or gastroesophageal adenocarcinoma.
- Conditions
- Gastric Cancer
- Being tested
- S-1, Oxaliplatin, Cadonilimab
- Keywords
- gastric cancer, neoadjuvant therapy, Cadonilimab
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1, Oxaliplatin, CadonilimabDrug
3 cycles of neoadjuvant therapy will be administered: S-1: 40~60mg Bid，d1~14, q3w Oxaliplatin：130mg/m2，iv drip，d1, q3w Cadonilimab（AK104）:10mg/Kg,iv drip,d1,q3w
| Study group | Role | What they receive |
|---|---|---|
| SOX+Cadonilimab（AK104） | Experimental | 3 cycles of neoadjuvant therapy: S-1: 40~60mg Bid，d1~14, q3w Oxaliplatin：130mg/m2，iv drip，d1, q3w Cadonilimab（AK104）:10mg/Kg,iv drip,d1,q3w Receives: Drug: S-1, Oxaliplatin, Cadonilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR)
evaluate pathological complete response rate of primary tumor and locally metastatic lymph nodes after 3 cycles of neoadjuvant therapy.
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Secondary outcomes (5)
R0 resection rate
Rate of microscopically margin-negative resection
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
2-year overall survival rate
Measured: 2 years
2-year disease free survival rate
Measured: 2 year
major pathological response (MPR)
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Safety and Tolerability
Treatment-related adverse events as assessed by CTCAE v4.0
Measured: 3 months after the last administration of drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study startJul 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Yu Ding, Sichuan University
- Investigators
- Jiankun Hu, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948449
- Sponsor's protocol ID
- WCH-2023-526
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang PF, Zhang WH, Liu XJ, He D, Yang K, Gou HF, Hu JK. Chemotherapy combined with cadonilimab (AK104) as neoadjuvant treatment for locally advanced gastric/gastro-oesophageal junction adenocarcinoma: study protocol for a single-arm, phase II clinical trial. BMJ Open. 2024 Dec 4;14(12):e081529. doi: 10.1136/bmjopen-2023-081529.
PubMed 39632107
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Chemotherapy Combined With Cadonilimab (AK104) in Neoadjuvant Treatment of Locally Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma: A Prospective, Single-arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT05948449
- Acronym / sponsor ID
- WCH-2023-526
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, neoadjuvant therapy, Cadonilimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 17 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.
The Purpose of This Study is to Evaluate the Efficacy and Safety of Cadonilimab（AK104） in Combination With SOX as Neoadjuvant Therapy for Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma.
Detailed description
Recent years, neoadjuvant therapy have emerged as a promising treatment option for the treatment of locally advanced gastric or gastroesophageal adenocarcinoma. However, the efficacy of current neoadjuvant regimens is still unsatisfactory. Novel treatment with higher efficacy and safety are urgently needed. Recently, immunotherapy has achieved significant therapeutic effects in the treatment of a series of cancers, and chemotherapy combined with immunotherapy has been recommended as the standard first-line treatment for gastric cancer. Moreover, several phase I/II studies have explored the efficacy and safety of chemotherapy combined with PD-1 inhibitor in the neoadjuvant treatment for gastric cancer, the results of which indicate that chemotherapy combined with immunotherapy can significantly improve the pCR rate and R0 resection rate of gastric cancer. In this study, we will evaluate the efficacy and safety of chemotherapy combined with Cadonilimab（AK104） (a PD-1/CTLA-4 bispecific antibody) in the neoadjuvant therapy for resectable locally advanced gastric or gastroesophageal adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOX+Cadonilimab（AK104） | Experimental | Drug: S-1, Oxaliplatin, Cadonilimab3 cycles of neoadjuvant therapy: S-1: 40~60mg Bid，d1~14, q3w Oxaliplatin：130mg/m2，iv drip，d1, q3w Cadonilimab（AK104）:10mg/Kg,iv drip,d1,q3w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age 18-75 years.
- Histologically or cytologically confirmed diagnosis of adenocarcinoma locate at gastroesophageal junction or stomach, advanced gastric or gastroesophageal junction cancer as assessed by ultrasonography and/or CT/MRI (cT3-T4a, N+, M0).
- Resectable gastric or gastroesophageal cancer, judged by surgeons in this study.
- No previous anti-tumor treatment.
- The expected survival is no less than 3 months.
Key exclusion criteria (34 listed)
- Unable to comply with the research program or procedures.
- Undergoing other drug clinical trials, or has participated in any drug clinical trials one month before enrollment.
- Active autoimmune disease or history of refractory autoimmune disease.
- Receiving corticosteroid (> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting.
- Active or clinically significant cardiac disease:
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 |
|---|---|---|
| S-1, Oxaliplatin, Cadonilimab3 cycles of neoadjuvant therapy will be administered: S-1: 40~60mg Bid，d1~14, q3w Oxaliplatin：130mg/m2，iv drip，d1, q3w Cadonilimab（AK104）:10mg/Kg,iv drip,d1,q3w | Drug | SOX+Cadonilimab（AK104） |
Primary outcome
Pathological complete response rate (pCR)
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
evaluate pathological complete response rate of primary tumor and locally metastatic lymph nodes after 3 cycles of neoadjuvant therapy.
5 secondary outcomes
R0 resection rate
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
2-year overall survival rate
Time frame: 2 years
2-year disease free survival rate
Time frame: 2 year
major pathological response (MPR)
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Safety and Tolerability
Time frame: 3 months after the last administration of drugs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Derived from this study: PubMed 39632107Zhang PF, Zhang WH, Liu XJ, He D, Yang K, Gou HF, Hu JK. Chemotherapy combined with cadonilimab (AK104) as neoadjuvant treatment for locally advanced gastric/gastro-oesophageal junction adenocarcinoma: study protocol for a single-arm, phase II clinical trial. BMJ Open. 2024 Dec 4;14(12):e081529. doi: 10.1136/bmjopen-2023-081529.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Jiankun Hu principal investigator
West China Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1, Oxaliplatin, Cadonilimab in people with Gastric Cancer, run by Sichuan University.
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 18 inclusion and 34 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 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Jiankun Hu, M.D (+86-18980601504, hujiankun@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR) (time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05948449, which also lists 1 linked publication.
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 17 Jul 2023.