Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ])Phase 3NCT06949033
Neoadjuvant Cadonilimab Combined With Perioperative Oxaliplatin Plus S1 for Diffuse or Mixed Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
A Phase 3 study testing Neoadjuvant cadonilimab combined with perioperative SOX in people with Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]) and Neoadjuvant Therapy, run by Zuoyi Jiao at 4 sites in China.
Trial summary
This study aims to investigate the efficacy and safety of neoadjuvant cadonilimab in combination with perioperative SOX chemotherapy, compared to perioperative SOX chemotherapy alone, in patients with diffuse or mixed-type locally advanced gastric or gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]), Neoadjuvant Therapy, Adjuvant Chemotherapy
- What is being tested?
- Neoadjuvant cadonilimab combined with perioperative SOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 668 participants
- Where
- 4 sitesChina
- Study dates
- 15 May 2025to 31 Dec 2030
- Phase
- Phase 3
- 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
- Type of Participant and Disease Characteristics
- Patients must have a pathologically confirmed diagnosis of HER-2 negative tumor and diffuse or mixed type gastric or gastroesophageal junction adenocarcinoma according to Lauren's histological subtypes.
- Patients must have previously untreated locally advanced gastric or gastroesophageal junction adenocarcinoma (stage cT2, cT3, cT4), with lymph nodes ranging from N1 to N3 and no evidence of metastatic disease (M0).
- Patients with Siewert type 2 or 3 tumors are eligible. Enrollment of participants with Siewert type 1 tumors will be limited to those for whom the planned treatment is perioperative chemotherapy and resection.
- Demographics
- Male or female subjects must be between the ages of ≥ 18 and ≤ 75 years at the time of signing the informed consent.
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- Expected Survival: The expected survival time must be ≥ 12 weeks.
- Performance Status: Subjects must have an ECOG performance status of 0 or 1 (refer to Appendix 1).
- Male Contraception: Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use an effective method of contraception from Day 1 through 120 days after receipt of the final dose of the investigational product. It is strongly recommended for the female partner of a male subject to also use an effective method of contraception throughout this period.
- Female subjects of childbearing potential must be willing to use adequate contraception methods throughout the study and for 120 days after the last dose of the study drug. The decision to discontinue contraception after this time point should be discussed with the attending physician. Periodic abstinence, contraceptive rhythm methods, and withdrawal are not acceptable forms of contraception.
- Females of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).
- Highly effective contraception methods, resulting in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, are required. Acceptable methods include a combination of a hormonal method (e.g., contraceptive pill) and a barrier method (e.g., male condom plus spermicide) to prevent pregnancy.
- Barrier methods include male condom plus spermicide, copper T intrauterine device, and levonorgestrel-releasing intrauterine system.
- Hormonal methods include implants, hormone injection, combined pill, minipill, and patch.
- If a female subject becomes pregnant or suspects pregnancy during her participation in the study or her partner's participation, she must promptly inform her treating physician.
- Organ Function
- Blood Routine (no blood transfusion within 14 days): WBC ≥ 3.0 × 10^9/L; ANC ≥ 1.5 × 10^9/L; PLT ≥ 100 × 10^9/L; HGB ≥ 80 g/L.
- Hepatic Function: Total bilirubin (TBIL) ≤ 1.5 × ULN, or direct bilirubin ≤ ULN for those with total bilirubin levels 1.5 × ULN and ALT/AST levels ≤ 2.5 × ULN.
- Renal Function: Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CrCl) ≥ 60 mL/min for those with Cr > 1.5 × ULN.
- Coagulation Function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN.
- Cardiac Function: Cardiac function will be assessed using electrocardiogram and color Doppler ultrasound, and subjects must have had no myocardial infarction within the last six months. Hypertension and other coronary heart diseases must be controllable.
- Females of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).
- Highly effective contraception methods, resulting in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, are required. Acceptable methods include a combination of a hormonal method (e.g., contraceptive pill) and a barrier method (e.g., male condom plus spermicide) to prevent pregnancy.
- Barrier methods include male condom plus spermicide, copper T intrauterine device, and levonorgestrel-releasing intrauterine system.
- Hormonal methods include implants, hormone injection, combined pill, minipill, and patch.
- If a female subject becomes pregnant or suspects pregnancy during her participation in the study or her partner's participation, she must promptly inform her treating physician.
- Informed Consent All subjects must provide written informed consent to participate in the study.
- Other Inclusions
- Prior Treatment: Patients must not have previously received any anti-tumor treatments, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
- Plan to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
- Be willing to provide tissue and blood sample from a tumor lesion at baseline and at time of surgery
Who cannot join
- Medical Conditions
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years (except for cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ that has undergone potentially curative therapy).
- Has an active infection requiring systemic therapy.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years. (NOTE: Subjects with vitiligo, alopecia, Grave's disease, Type I diabetes mellitus, hypothyroidism (e.g., following Hashimoto's syndrome) only requiring hormone replacement on a stable dose (without adjustment in the first 4 weeks of study treatment), psoriasis or eczema not requiring systemic treatment (within the past 2 years), or conditions not expected to recur in the absence of an external trigger are not excluded.)
- Has any complications requiring systemic treatment with corticosteroids such as prednisone (> 10mg/day) or other immunosuppressive medications within 14 days prior to the first administration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
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- History of primary immunodeficiency.
- Has received a live vaccine or other immune-activating anti-tumor drugs (such as interferon, interleukin, thymosin, or immunotherapy) within 30 days prior to the first dose of study treatment.
- Has a known history of active tuberculosis.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Has a known severe allergy or hypersensitivity to cadonilimab or sintilimab or any of the study chemotherapy agents and/or to any of their excipients.
- Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors:
- Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 480 ms), grade III or IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) < 50.0% as determined by color Doppler echocardiography.
- Cerebrovascular accident, transient ischemic attack, or other arteriovenous thrombotic, embolic, or ischemic events.
- Prior/Concomitant Therapy
- Subjects who have already enrolled in another clinical study, unless it is an observational, non-interventional clinical study, or they are in the follow-up period for an interventional study (the time between the first dose of cadonilimab and the last dose in the previous clinical study should be more than 4 weeks or 5 times the half-life of the previous study drug).
- Subjects who have received any systemic or curative anti-tumor therapy, including radiotherapy, chemotherapy, targeted therapy.
- Subjects who have previously received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug therapy targeting T-cell co-stimulation or checkpoint pathway, e.g. ICOS or agonists (e.g., CD40, CD137, GITR, and OX40, etc.).
- Other exclusion criteria
- Confirmed HER-2 positive tumor will be excluded.
- Patients could not provide tumor samples and blood samples.
- Pregnant or lactating patients, as well as patients with childbearing potential who plan to be pregnant within 5 months after the study; Women of childbearing should receive a blood pregnancy test within 7 days before the study
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Gansu Provincial Hospital
Lanzhou, Gansu, 730000
Xiaoning Zhao, +86-18993113172, 19239234@qq.com
Xiaoning Zhao
- Recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730000
Bo Long, +86 130 0878 1208, longbo_107@163.com
Bo Long
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Da Zhao, +86-13893230123, zhaodamail@163.com
Da Zhao
- Recruiting
The Gastrointestinal Surgery Department, Sun Yat-sen University Cancer Center Gansu Hospital
Lanzhou, Gansu, 730000
Dengwen Wei, +86-13919916710, dengwen002@163.com
Dengwen Wei
About this study
This study aims to investigate the efficacy and safety of neoadjuvant cadonilimab in combination with perioperative SOX chemotherapy, compared to perioperative SOX chemotherapy alone, in patients with diffuse or mixed-type locally advanced gastric or gastroesophageal junction adenocarcinoma. The main questions it seeks to answer are:
- Is neoadjuvant cadonilimab plus SOX chemotherapy superior to neoadjuvant placebo plus SOX chemotherapy in terms of the pathological complete response (pCR) rate at the time of surgery?
- To evaluate and compare the 3-year OS rate in patients receiving neoadjuvant cadonilimab plus SOX chemotherapy versus patients receiving placebo plus neoadjuvant SOX chemotherapy regimen.
Read more
Participants will be divided into two groups:
- Experimental group: Participants will receive intravenous cadonilimab (10 mg/kg) in combination with the SOX regimen (oxaliplatin 130 mg/m² and S-1, with the initial dose determined based on body surface area).
- Control group: Participants will receive a placebo in combination with the SOX regimen.
After completing 3-4 cycles of treatment, patients in both the experimental and control groups will undergo radical surgery with D2 or D2+ lymphadenectomy. Following surgery, patients will receive 4 cycles of adjuvant SOX chemotherapy at 70% of the standard dosage, administered every 21 days, starting within 3-6 weeks post-surgery.
- Conditions
- Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]), Neoadjuvant Therapy, Adjuvant Chemotherapy, pCR Rate, MPR, ORR,OS,PFS
- Being tested
- Neoadjuvant cadonilimab combined with perioperative SOX, Neoadjuvant placebo plus perioperative SOX
- Keywords
- gastric cancer, Diffuse or Mixed type, Cadonilimab, Oxaliplatin, S1
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant cadonilimab combined with perioperative SOXDrug
Cadonilimab: 10 mg/kg, iv, day 1 of every 3 weeks Oxaliplatin: 130 mg/m², iv, day 1 of every 3 weeks S1: 40-60 mg/m², po, day 1-14 of every 3 weeks (BSA < 1.25 m², 40 mg * 2/day, 1.25 m² ≤ BSA < 1.5 m², 50 mg * 2/day, BSA ≥ 1.5 m², 60 mg * 2/day)
Neoadjuvant placebo plus perioperative SOXDrug
Placebo: iv, day 1 of every 3 weeks Oxaliplatin: 130 mg/m², iv, day 1 of every 3 weeks S1: 40-60 mg/m², po, day 1-14 of every 3 weeks (BSA < 1.25 m², 40 mg * 2/day, 1.25 m² ≤ BSA < 1.5 m², 50 mg * 2/day, BSA ≥ 1.5 m², 60 mg * 2/day)
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant cadonilimab combined with perioperative SOX group | Experimental | Participants will receive intravenous cadonilimab (10 mg/kg) in combination with the SOX regimen (oxaliplatin 130 mg/m² and S-1 at a dose of 40-60 mg/m²) for a total of three or four cycles. Subsequently, patients will undergo radical surgery with D2 or D2+ lymphadenectomy. Adjuvant chemotherapy will commence on the 21st or 42st day after surgery, consisting of four cycles of SOX chemotherapy in both groups, administered once every three weeks. Receives: Drug: Neoadjuvant cadonilimab combined with perioperative SOX |
| Neoadjuvant placebo plus perioperative SOX | Placebo comparator | Participants will receive intravenous placebo in combination with the SOX regimen (oxaliplatin 130 mg/m² and S-1 at a dose of 40-60 mg/m²) for a total of three or four cycles. Subsequently, patients will undergo radical surgery with D2 or D2+ lymphadenectomy. Adjuvant chemotherapy will commence on the 21st or 42st day after surgery, consisting of four cycles of SOX chemotherapy in both groups, administered once every three weeks. Receives: Drug: Neoadjuvant placebo plus perioperative SOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate
The pCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes as assessed by BIPR based on Becker regression criteria. pCR rate is defined as the proportion of participants having pCR.
Measured: From enrollment to surgical treatment, it is expected to require 4 months.
3-year survival rate (3-year OS rate)
3-year OS rate is defined as the proportion of patients alive at 3 years after randomization estimated using the Kaplan-Meier method. Participants without documented death at the time of analysis will be censored at the date of last known alive.
Measured: 3 years
Secondary outcomes (10)
Major pathological response (MPR) rate
MPR rate by BIPR is defined as the proportion of patients with ≤ 10% residual viable tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant therapy as assessed by BIPR.
Measured: From enrollment to surgical treatment, it is expected to require 4 months.
Objective response rate (ORR)
ORR is defined as the proportion of patients who had complete response (CR) or partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in all randomized patients with measurable disease at baseline.
Measured: From enrollment to preoperative imaging evaluation, it is expected to require 3-4 months.
Treatment emergent adverse event
Incidence and severity of TEAEs, including serious adverse events (SAEs) and immune-mediated adverse events (imAEs), with severity determined according to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
Measured: From enrollment to the completion or discontinuation of treatment, an estimated duration of eight months is expected.
Disease control rate (DCR)
DCR is defined as the proportion of patients who had CR, PR or stable disease (SD) as assessed by BICR per RECIST v1.1 in all randomized patients with measurable disease at baseline.
Measured: From enrollment to preoperative imaging evaluation, it is expected to require 3-4 months.
3-year BICR-assessed disease-free survival (DFS) rate
3-year BICR-assessed DFS rate is defined as the time from the first date of surgery with R0 resection to local or distant recurrence or death due to any cause, whichever occurs first, as determined by BICR during the adjuvant treatment and safety follow-up.
Measured: 3 years
R0 resection rate
R0 resection rate is defined as the proportion of patients who had no cancer cells could be found at the surgical margins under the microscope, indicating complete removal of the lesion with no residual tumor visible either macroscopically or microscopically.
Measured: From enrollment to surgical treatment, it is expected to require 4 months.
Surgery-related complications
Surgery-related complications is defined as patients who received surgery within 30 days and experienced any grade surgery-related complications per Clavien-Dindo Classification of Surgical Complications, including vomiting, fever, incision infection, post-operative pneumonia, anastomotic hemorrhage or leakage, chylous leakage, pneumonia, intestinal obstruction, etc,
Measured: After the completion of surgery, it is expected to take 5 months.
Tumor downstage rate
The tumor downstage rate is defined as the proportion of patients who had overall ypTNM or T or N stage was decreased from cTNM, cT or cN stage at baseline. Tumor stage was evaluated based on baseline cTNM stage and postoperative ypTNM stage according to the 8th edition of the AJCC Gastric Cancer Stage.
Measured: After the completion of surgery, it is expected to take 4 months.
Programmed death ligand-1 Combined Positive Score (PD-L1 CPS)
PD-L1 expression as the predictive biomarker for efficacy (including but not limited to pCR rate, MPR rate, 3-year OS rate, and 3-year DFS rate). The CPS score ranges from 0 to 100. High levels of PD-L1 expression are usually associated with better responses to immunotherapy, and patients may benefit more from immune checkpoint inhibitors.
Measured: Baseline
Microsatellite Instability (MSI)
The status of MSI as the predictive biomarker for efficacy (including but not limited to pCR rate, MPR rate, 3-year OS rate, and 3-year DFS rate).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start15 May 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ])Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 668 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuoyi Jiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zuoyi Jiao, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949033
- Sponsor's protocol ID
- LanzhouU2H-2025A-017
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Cadonilimab Combined With Perioperative Oxaliplatin Plus S1 for Diffuse or Mixed Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06949033
- Acronym / sponsor ID
- LanzhouU2H-2025A-017
- Conditions
- Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]), Neoadjuvant Therapy, Adjuvant Chemotherapy, pCR Rate, MPR, ORR,OS,PFS
- Keywords
- gastric cancer, Diffuse or Mixed type, Cadonilimab, Oxaliplatin, S1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 668 participants (estimated)
- Lead sponsor
- Zuoyi JiaoUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 Apr 2025 (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 study aims to investigate the efficacy and safety of neoadjuvant cadonilimab in combination with perioperative SOX chemotherapy, compared to perioperative SOX chemotherapy alone, in patients with diffuse or mixed-type locally advanced gastric or gastroesophageal junction adenocarcinoma. The main questions it seeks to answer are:
- Is neoadjuvant cadonilimab plus SOX chemotherapy superior to neoadjuvant placebo plus SOX chemotherapy in terms of the pathological complete response (pCR) rate at the time of surgery?
- To evaluate and compare the 3-year OS rate in patients receiving neoadjuvant cadonilimab plus SOX chemotherapy versus patients receiving placebo plus neoadjuvant SOX chemotherapy regimen.
Participants will be divided into two groups:
- Experimental group: Participants will receive intravenous cadonilimab (10 mg/kg) in combination with the SOX regimen (oxaliplatin 130 mg/m² and S-1, with the initial dose determined based on body surface area).
- Control group: Participants will receive a placebo in combination with the SOX regimen.
After completing 3-4 cycles of treatment, patients in both the experimental and control groups will undergo radical surgery with D2 or D2+ lymphadenectomy. Following surgery, patients will receive 4 cycles of adjuvant SOX chemotherapy at 70% of the standard dosage, administered every 21 days, starting within 3-6 weeks post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant cadonilimab combined with perioperative SOX group | Experimental | Drug: Neoadjuvant cadonilimab combined with perioperative SOXParticipants will receive intravenous cadonilimab (10 mg/kg) in combination with the SOX regimen (oxaliplatin 130 mg/m² and S-1 at a dose of 40-60 mg/m²) for a total of three or four cycles. Subsequently, patients will undergo radical surgery with D2 or D2+ lymphadenectomy. Adjuvant chemotherapy will commence on the 21st or 42st day after surgery, consisting of four cycles of SOX chemotherapy in both groups, administered once every three weeks. |
| Neoadjuvant placebo plus perioperative SOX | Placebo comparator | Drug: Neoadjuvant placebo plus perioperative SOXParticipants will receive intravenous placebo in combination with the SOX regimen (oxaliplatin 130 mg/m² and S-1 at a dose of 40-60 mg/m²) for a total of three or four cycles. Subsequently, patients will undergo radical surgery with D2 or D2+ lymphadenectomy. Adjuvant chemotherapy will commence on the 21st or 42st day after surgery, consisting of four cycles of SOX chemotherapy in both groups, administered once every three weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Type of Participant and Disease Characteristics
- Demographics
- Organ Function
- Informed Consent All subjects must provide written informed consent to participate in the study.
- Other Inclusions
Key exclusion criteria (22 listed)
- Medical Conditions
- Prior/Concomitant Therapy
- Other exclusion criteria
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 |
|---|---|---|
| Neoadjuvant cadonilimab combined with perioperative SOXCadonilimab: 10 mg/kg, iv, day 1 of every 3 weeks Oxaliplatin: 130 mg/m², iv, day 1 of every 3 weeks S1: 40-60 mg/m², po, day 1-14 of every 3 weeks (BSA < 1.25 m², 40 mg * 2/day, 1.25 m² ≤ BSA < 1.5 m², 50 mg * 2/day, BSA ≥ 1.5 m², 60 mg * 2/day) | Drug | Neoadjuvant cadonilimab combined with perioperative SOX group |
| Neoadjuvant placebo plus perioperative SOXPlacebo: iv, day 1 of every 3 weeks Oxaliplatin: 130 mg/m², iv, day 1 of every 3 weeks S1: 40-60 mg/m², po, day 1-14 of every 3 weeks (BSA < 1.25 m², 40 mg * 2/day, 1.25 m² ≤ BSA < 1.5 m², 50 mg * 2/day, BSA ≥ 1.5 m², 60 mg * 2/day) | Drug | Neoadjuvant placebo plus perioperative SOX |
Primary outcome
Pathological complete response (pCR) rate
Time frame: From enrollment to surgical treatment, it is expected to require 4 months.
The pCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes as assessed by BIPR based on Becker regression criteria. pCR rate is defined as the proportion of participants having pCR.
3-year survival rate (3-year OS rate)
Time frame: 3 years
3-year OS rate is defined as the proportion of patients alive at 3 years after randomization estimated using the Kaplan-Meier method. Participants without documented death at the time of analysis will be censored at the date of last known alive.
10 secondary outcomes
Major pathological response (MPR) rate
Time frame: From enrollment to surgical treatment, it is expected to require 4 months.
Objective response rate (ORR)
Time frame: From enrollment to preoperative imaging evaluation, it is expected to require 3-4 months.
Treatment emergent adverse event
Time frame: From enrollment to the completion or discontinuation of treatment, an estimated duration of eight months is expected.
Disease control rate (DCR)
Time frame: From enrollment to preoperative imaging evaluation, it is expected to require 3-4 months.
3-year BICR-assessed disease-free survival (DFS) rate
Time frame: 3 years
R0 resection rate
Time frame: From enrollment to surgical treatment, it is expected to require 4 months.
Surgery-related complications
Time frame: After the completion of surgery, it is expected to take 5 months.
Tumor downstage rate
Time frame: After the completion of surgery, it is expected to take 4 months.
Programmed death ligand-1 Combined Positive Score (PD-L1 CPS)
Time frame: Baseline
Microsatellite Instability (MSI)
Time frame: Baseline
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 10 Jul 2025.
- Individual participant dataSharing planned: No
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neoadjuvant cadonilimab combined with perioperative SOX in people with Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]) and Neoadjuvant Therapy, run by Zuoyi Jiao at 4 sites 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 31 inclusion and 22 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 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Bo Long (+86 130 0878 1208, longbo_107@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate (time frame: From enrollment to surgical treatment, it is expected to require 4 months.). 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 10 Jul 2025.