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CLDN18.2 PositivePhase 2NCT07483567

IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing IBI343,sintilimab,oxaliplatin,S-1 and sintilimab,oxaliplatin,S-1 in people with CLDN18.2 Positive and Primary Gastric Adenocarcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a prospective, randomized, open, multicenter phase II clinical trial. It plans to enroll 70 participants with locally advanced gastric and gastroesophageal junction adenocarcinoma (G/GEJ AC) who are assessed as suitable for D2 radical surgery and capable of R0 resection.To evaluate the clinical efficacy… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
IBI343,sintilimab,oxaliplatin,S-1 and sintilimab,oxaliplatin,S-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
17 Apr 2026to 30 Jun 2031
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

  • Signed written informed consent and able to comply with the visit and related procedures as specified in the protocol.
  • Male or female, 18 years ≤ age ≤ 75 years;
  • ECOG score 0-1;
  • Histologically confirmed, previously untreated patients with gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction; only Siewert II/III type participants are allowed for gastroesophageal junction cancer;
  • Clinical staging based on enhanced CT/MRI examination, clinical stage T3~4a with positive lymph nodes, and no distant metastasis;
  • The research center and surgeon can perform radical D2 lymph node dissection surgery, R0 resection;
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  • Physical condition and organ function allow for major abdominal surgery;
  • Confirmed CLDN18.2 expression by central laboratory pathological tissue testing.
  • Adequate organ and bone marrow function.
  • Echocardiography confirms left ventricular ejection fraction (LVEF) ≥ 50%;
  • Female participants must agree not to breastfeed from screening through the entire treatment period and up to 6 months after the last dose.
  • Female participants of childbearing potential or male participants whose partners are of childbearing potential must use effective contraception from screening through the entire treatment period and up to 9 months after the last dose.

Who cannot join

  • HER2 positive.
  • Currently participating in another interventional clinical study, except for those in the follow-up phase of an interventional study.
  • Previous use of traditional Chinese medicine, Chinese patent medicines, or immunomodulators must be ≥2 weeks before starting the study medication.
  • Received treatment with a strong CYP3A4 inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug.
  • Received any live vaccine within 4 weeks prior to the first dose of the study drug or plans to receive any during the study period.
  • Underwent major surgery (craniotomy, thoracotomy, laparotomy, laparoscopic resection of significant tissues or organs, or other as defined by the investigator, excluding needle biopsies) within 4 weeks prior to the first dose of the study drug, or has unhealed wounds, ulcers, or fractures.
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  • Patients who received steroids (>10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days before enrollment. However, patients are allowed to enroll if they use topical or inhaled steroids, or adrenal replacement therapy with ≤10 mg/day prednisone equivalent, without active autoimmune disease.
  • History of interstitial lung disease, non-infectious pneumonia, severely impaired pulmonary function, or uncontrolled pulmonary disease such as pulmonary fibrosis, severe radiation pneumonitis, acute lung injury, etc., or suspected of having such conditions during the screening period.
  • Presence of uncontrolled diseases, such as:
  • Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).
  • Any arterial thromboembolic event within 6 months prior to the first dose of the study drug, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, etc.
  • History of deep vein thrombosis (patients stable on anticoagulation for at least 2 weeks can be enrolled), pulmonary embolism, or any other serious venous thromboembolic event within 3 months prior to the first dose of the study drug (implantable venous port or catheter-related thrombosis, or superficial venous thrombosis, are not considered "serious" venous thromboembolic events).
  • Any life-threatening bleeding event or Grade 3 or 4 gastrointestinal/variceal bleeding event requiring transfusion, endoscopic, or surgical intervention within 3 months prior to the first dose of the study drug.
  • Hepatic encephalopathy, hepatorenal syndrome, Child-Pugh B or more severe liver cirrhosis.
  • Complete or partial intestinal obstruction present during the screening period or history of complete or partial intestinal obstruction within 3 months prior to the first dose of the study drug, or risk of bowel perforation (including but not limited to acute diverticulitis, history of intra-abdominal abscess) or history of inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
  • Other acute or chronic diseases or laboratory abnormalities that may result in: increased risk related to participation in the study or administration of the study drug, interference with the interpretation of study results, and participants deemed ineligible for the study by the investigator.
  • Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary reactions to cancer (such as leukemoid reaction, etc.), which may lead to higher medical risks and/or uncertainty in survival evaluation.
  • Neurological, psychiatric, or social conditions that: affect compliance with study requirements, significantly increase the risk of adverse events, or impair the ability of the participant to provide written informed consent.
  • History of other primary malignant tumors.
  • Known history of immunodeficiency.
  • History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • History of allergic reactions to the drugs used in this study.
  • Other conditions deemed unsuitable for participation in this study by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shuang Han contact

+8651269566088

shuang.han@innoventbio.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Ziyu Li, +8601088196605, ligregory369@hotmail.com

    Ziyu Li, PhD

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Open-label, Multicenter Phase II Clinical Study to Explore the Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma With IBI343 in Combination With Sintilimab and SOX Regimen.

This study is a prospective, randomized, open, multicenter phase II clinical trial. It plans to enroll 70 participants with locally advanced gastric and gastroesophageal junction adenocarcinoma (G/GEJ AC) who are assessed as suitable for D2 radical surgery and capable of R0 resection.To evaluate the clinical efficacy and tolerability of IBI343 in combination with sintilimab and SOX regimen for perioperative treatment of resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma.Enroll patients who are CLDN18.2 positive.

Being tested
IBI343,sintilimab,oxaliplatin,S-1, sintilimab,oxaliplatin,S-1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI343,sintilimab,oxaliplatin,S-1Drug

    IBI343,sintilimab,oxaliplatin,S-1

  • sintilimab,oxaliplatin,S-1Drug

    sintilimab,oxaliplatin,S-1

Study groups in NCT07483567
Study groupRoleWhat they receive
experimental groupExperimentalNot described
Receives: Drug: IBI343,sintilimab,oxaliplatin,S-1
control groupActive comparatorNot described
Receives: Drug: sintilimab,oxaliplatin,S-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response rate (pCR rate): defined as the proportion of participants who, after surgery, show complete regression of tumor cells in the primary lesion and lymph node lesions according to pathological examination.

    Measured: Up to 4 years

  2. Dose-limiting toxicity (DLT), to determine MTD and/or RP2D

    Measured: Up to 4 years

Secondary outcomes (21)

  1. Event-free survival (EFS)

    Defined as the time from the first dose (randomization) to the first determination of disease progression according to RECIST v1.1, or inability to undergo surgery or need for a change in treatment due to disease progression, local recurrence after surgery or distant metastasis, or death from any cause.

    Measured: Up to 4 years

  2. Major pathologic response rate (MPR)：The proportion of participants with postoperative pathology showing residual tumor cells ≤10%.

    Measured: Up to 2 years

  3. Clinical downstaging rate (T and/or N downstaging)：The proportion of participants who are ypT0, ypN0, and have a downstaging in preoperative imaging clinical staging compared to baseline imaging clinical staging.

    Measured: Up to 2 years

  4. 3-year disease-free survival (3y-DFS)：Defined as the time from R0 resection to the first recorded disease recurrence, metastasis, or death from any cause.

    Measured: Up to 2 years

  5. 5-year overall survival (5y-OS)：Defined as the time from the first dose or randomization date to death from any cause.

    Measured: Up to 2 years

  6. Preoperative objective response rate (ORR) evaluated according to RECIST v1.1.

    Measured: Up to 2 years

  7. Preoperative disease control rate (DCR) evaluated according to RECIST v1.1.

    Measured: Up to 2 years

  8. Adverse Event (AE) incidence and correlation with the investigational drug

    Measured: Up to 2 years

  9. Treatment-Emergent Adverse Event (TEAE) incidence and correlation with the investigational drug.

    Measured: Up to 2 years

  10. Adverse Event of Special Interest (AESI) incidence and correlation with the investigational drug.

    Measured: Up to 2 years

  11. Serious Adverse Event (SAE) incidence and correlation with the investigational drug.

    Measured: Up to 2 years

  12. Incidence of perioperative complications and their correlation with the investigational drug.

    Measured: Up to 2 years

  13. Area under the curve of drug concentration over time for participants treated with IBI343.

    Measured: Up to 2 years

  14. Maximum concentration (Cmax) for participants treated with IBI343.

    Measured: Up to 2 years

  15. Clearance (CL) for participants treated with IBI343.

    Measured: Up to 2 years

  16. Volume of distribution (V) for participants treated with IBI343.

    Measured: Up to 2 years

  17. Half-life for participants treated with IBI343.

    Measured: Up to 2 years

  18. Positive rate of anti-drug antibodies for participants treated with IBI343.

    Measured: Up to 2 years

  19. Positive rate of neutralizing antibodies for participants treated with IBI343.

    Measured: Up to 2 years

  20. The number of participants with abnormal laboratory test results

    Measured: Up to 2 years

  21. the number of participants showing clinically significant findings during physical examination

    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.

  1. First posted19 Mar 2026
  2. Study start17 Apr 2026
  3. Primary completion30 Jun 2030 (estimated)
  4. Study completion30 Jun 2031 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07483567
Sponsor's protocol ID
CIBI343A203
Status last verified
May 2026
First submitted
16 Mar 2026
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IBI343,sintilimab,oxaliplatin,S-1 and sintilimab,oxaliplatin,S-1 in people with CLDN18.2 Positive and Primary Gastric Adenocarcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. 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 12 inclusion and 23 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 2 Jun 2026. 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 Shuang Han (+8651269566088, shuang.han@innoventbio.com), 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 rate): defined as the proportion of participants who, after surgery, show complete regression of tumor cells in the primary lesion and lymph node lesions according to pathological examination. (time frame: Up to 4 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?

On the ClinicalTrials.gov record for NCT07483567.

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 2 Jun 2026.

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