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Gastric CancerPhase 2NCT06580574

Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers

A Phase 2 study testing PD1/PDL1 antibody monotherapy, up to 24 weeks, Intensive immunotherapy plus anti-VEGF treatment, up to 24 weeks and Radical surgery in people with Gastric Cancer and Colon Cancer, run by Peking University 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 intends to explore the role of PD1/PDL1 antibody with selective combination of Sintilimab, IBI310 and Lenvatinib in organ preservation in non-metastatic dMMR/MSI-H gastric or colon cancers with mismatch repair deficiency or high microsatellite instability Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, Colon Cancer, MSI-H
What is being tested?
PD1/PDL1 antibody monotherapy, up to 24 weeks, Intensive immunotherapy plus anti-VEGF treatment, up to 24 weeks and Radical surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
13 Sep 2024to 1 Jun 2029
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects are able to comprehend the informed consent form, and voluntarily sign the informed consent form.
  • Subjects are ≥18 years old on the day of signing the informed consent form, with no gender restrictions.
  • Histologically confirmed gastric cancer or colon cancer, without distant metastasis based on CR or MR.
  • ECOG performance status of 0-2.
  • dMMR confirmed by immunohistochemistry or MSI-H confirmed by PCR and NGS. If MSI status and MMR status were not consistent, whether to enroll this patient should be determine by investigators. Patients with MMR heterogeneity in tumors could not be included.
  • Patients who are about to receive or are receiving 24 weeks of PD1/PDL1 antibody monothearpy and have not had the first efficacy assessment.
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  • Archived tumor tissue samples or freshly obtained tumor tissue samples are available.
  • Female subjects of childbearing potential or male subjects with partners of childbearing potential agree to use highly effective contraception from 7 days before the first dose until 120 days after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose.
  • Subjects have the ability and willingness to comply with the study protocol's visits, treatment plan, laboratory tests, and other study-related procedures.
  • For patients who are about to receive combination of Sintilimab, IBI310 and Lenvatinib. subjects should have good organ function within the first 7 days of initial dosing: HGB ≥ 80g/L, NEU ≥ 1.0*10^9/L, PLT ≥ 75*10^9/L, Cr≤1.5×ULN or CrCl≥50mL/min（Cockcroft-Gault method), TBiL ≤ 1.5×ULN, ALT and AST ≤3 ×ULN; urine protein <2+; if urine protein ≥ 2+, 24 hour urinary protein quantity <2g; INR, APTT, PT ≤ 1.5 ×ULN

Who cannot join

  • Distant metastasis;
  • Previous treatment including CTLA4 blockade;
  • Subjects with interstitial lung disease or a history of non-infectious pneumonia requiring oral or intravenous corticosteroid treatment.
  • Subjects with active autoimmune diseases requiring systemic treatment before the start of the study or those considered at risk of recurrence or planned treatment for autoimmune diseases as judged by the investigator. Except for these conditions: a) skin diseases that do not require systemic treatment (e.g., vitiligo, alopecia, psoriasis, or eczema); b) hypothyroidism caused by autoimmune thyroiditis, requiring stable doses of hormone replacement therapy; c) type 1 diabetes requiring stable doses of insulin replacement therapy; d) childhood asthma fully resolved with no need for intervention in adulthood; e) the investigator judges that the disease will not relapse without external triggering factors.
  • Subjects with a history of other malignant tumors within 5 years, excluding cured skin squamous cell carcinoma, basal cell carcinoma, non-invasive bladder carcinoma, localized low-risk prostate cancer (defined as stage ≤T2a, Gleason score ≤6, and prostate-specific antigen (PSA) ≤10 ng/mL (if measured) in patients who have undergone curative treatment and have no biochemical recurrence of prostate-specific antigen (PSA)), in situ cervical/breast carcinoma, or Lynch syndrome.
  • Subjects with uncontrolled comorbidities, including but not limited to: a) active HBV or HCV infection; b) subjects who are HBsAg positive and/or HCV antibody positive during screening must undergo HBV DNA and/or HCV RNA testing. Only subjects with HBV DNA ≤500 IU/mL (or ≤2000 copies/mL) and/or HCV RNA negative can be enrolled; HBV DNA monitoring will be at the discretion of the investigator based on the subject's condition during the trial; c) known HIV infection or AIDS history; d) active tuberculosis; e) uncontrolled hypertension (resting blood pressure ≥160/100 mmHg), symptomatic congestive heart failure (NYHA II-IV), unstable angina or myocardial infarction within 6 months, or the presence of QTc prolongation or the risk of arrhythmia (baseline QTc >470 msec <Fridericia method correction>, refractory hypokalemia, long QT syndrome, atrial fibrillation with resting heart rate >100 bpm, or severe valvular heart disease); f) active bleeding that cannot be controlled after medical treatment.
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  • History of allogeneic bone marrow or organ transplantation.
  • Previous history of allergic reactions, hypersensitivity reactions, or intolerance to antibody drugs (e.g., severe allergic reactions, immune-mediated hepatotoxicity, immune-mediated thrombocytopenia, or anemia).
  • Pregnant and/or lactating females.
  • For patients who are about to receive combination of Sintilimab, IBI310 and Lenvatinib: a) Subjects with a history of gastrointestinal perforation or fistula within 6 months before the first dose. If the perforation or fistula has been treated with resection or repair, and the disease is judged to be recovered or improved by the investigator, then enrollment is allowed. b) Subjects who have undergone major surgery within 28 days before the first dose (e.g., major abdominal or thoracic surgery; excluding drainage, diagnostic puncture, or peripheral vascular access replacement). c) Subjects who require systemic corticosteroids (≥10 mg/day prednisone or equivalent) or immunosuppressive therapy for a continuous 7-day period within 14 days before the first dose. Inhaled or locally applied steroids and physiological replacement doses of steroids due to adrenal insufficiency are allowed. Short-term (≤7 days) corticosteroids for prophylaxis (e.g., contrast dye allergy) or treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reaction caused by exposure to allergens) are allowed. d) Toxicity from previous antitumor treatments has not recovered to Grade ≤2 (NCI-CTCAE v5.0) or baseline, except for alopecia, skin pigmentation (allowed at any level), and immune-related adverse reactions requiring physiological replacement (e.g., hypothyroidism, hypopituitarism, type 1 diabetes).

Trial locations and contacts

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

Lin Shen contact

010-88196561

shenlin@bjmu.edu.cn

Zhenghang Wang contact

010-88196088

zhenghang_wang@bjmu.edu.cn

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Zhenghang Wang, Dr, 010-88196088, zhenghang_wang@bjmu.edu.cn

    Lin Shen, Dr

    Recruiting

Other trials in China

About this study

Official title: PD-1/PD-L1 Antibody With Selective Combination of Sintilimab, IBI310 and Lenvatinib Used for Organ Preservation in Non-metastatic Gastric or Colon Cancers With Mismatch Repair Deficiency or High Microsatellite Instability

This study intends to explore the role of PD1/PDL1 antibody with selective combination of Sintilimab, IBI310 and Lenvatinib in organ preservation in non-metastatic dMMR/MSI-H gastric or colon cancers with mismatch repair deficiency or high microsatellite instability

Being tested
PD1/PDL1 antibody monotherapy, up to 24 weeks, Intensive immunotherapy plus anti-VEGF treatment, up to 24 weeks, Radical surgery
Keywords
Organ preservation, immunotherapy, anti-VEGF
Medical subject headings
Stomach Neoplasms, Colonic Neoplasms

What participants receive

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

  • PD1/PDL1 antibody monotherapy, up to 24 weeksDrug

    non-specific, according to Drug Instructions

  • Intensive immunotherapy plus anti-VEGF treatment, up to 24 weeksCombination product

    Sintilimab 200mg, ivgtt, q21d; IBI310 1mg/kg, ivgtt, q42d; Lenvatinib 8mg (starting from 4mg), po, qd

  • Radical surgeryProcedure or surgery

    Radical surgery will be recommended per local treatment standards.

Study groups in NCT06580574
Study groupRoleWhat they receive
dMMR/MSI-H gastric cancerExperimentalPD1/PDL1 antibody monotherapy will be given per local treatment standards. If (near-) clinical complete response is not achieved after 24 weeks of PD1/PDL1 antibody monotherapy, then combination of intensive immunotherapy plus anti-VEGF treatment will be used. If (near-) clinical complete response is not achieved after 24 weeks of intensive immunotherapy plus anti-VEGF treatment, radical surgery will be recommended.
Receives: Drug: PD1/PDL1 antibody monotherapy, up to 24 weeks; Combination Product: Intensive immunotherapy plus anti-VEGF treatment, up to 24 weeks; Procedure: Radical surgery
dMMR/MSI-H colon cancerExperimentalPD1/PDL1 antibody monotherapy will be given per local treatment standards. If (near-) clinical complete response is not achieved after 24 weeks of PD1/PDL1 antibody monotherapy, then combination of intensive immunotherapy plus anti-VEGF treatment will be used. If (near-) clinical complete response is not achieved after 24 weeks of intensive immunotherapy plus anti-VEGF treatment, radical surgery will be recommended.
Receives: Drug: PD1/PDL1 antibody monotherapy, up to 24 weeks; Combination Product: Intensive immunotherapy plus anti-VEGF treatment, up to 24 weeks; Procedure: Radical surgery

What is being measured

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

  1. Organ preservation rate

    The rate of patients who achieved cCR or near-cCR and did not undergo surgery after completion of established therapy, assessed among all patients who completed established therapy.

    Measured: The status of cCR or near-cCR and the possibility of organ preservation will be evaluated after completion of PD1/PDL1 antibody monotherapy, 12 weeks after Sintilimab, IBI310 and Lenvatinib, and 24 weeks after Sintilimab, IBI310 and Lenvatinib

Secondary outcomes (16)

  1. Organ preservation rate after completion of PD1/PDL1 antibody monotherapy

    The rate of patients who achieve cCR or near-cCR and do not undergo surgery after completion of PD1/PDL1 antibody monotherapy, assessed among all patients who completed PD1/PDL1 antibody monotherapy

    Measured: The status of cCR or near-cCR and the possibility of organ preservation will be evaluated after completion of PD1/PDL1 antibody monotherapy, an average of 24 weeks

  2. Organ preservation rate after completion of selective combination of Sintilimab, IBI310 and Lenvatinib

    The rate of patients who achieved cCR or near-cCR and did not undergo surgery after completion of selective combination of Sintilimab, IBI310 and Lenvatinib, assessed among all patients who do not achieve cCR or near-cCR after PD1/PDL1 antibody monotherapy, and all patients who achieve cCR or near-cCR after PD1/PDL1 antibody monotherapy but have disease progression during follow-up

    Measured: The status of cCR or near-cCR and the possibility of organ preservation will be evaluated 12 weeks and 24 weeks after Sintilimab, IBI310 and Lenvatinib

  3. Objective response rate of selective combination of Sintilimab, IBI310 and Lenvatinib

    Objective response rate (defined as CR+PR) will be reported based on investigator's evaluation according to RECIST 1.1

    Measured: Baseline up to withdrawal of consent, progressive disease, unacceptable toxicity, or surgery (whichever occurs first), up to 8 years

  4. Disease control rate of selective combination of Sintilimab, IBI310 and Lenvatinib

    Disease control rate (defined as CR+PR+SD) will be reported based on investigator's evaluation according to RECIST 1.1

    Measured: Baseline up to withdrawal of consent, progressive disease, unacceptable toxicity, or surgery (whichever occurs first), up to 8 years

  5. 3 year organ preservation rate

    Rate of 3 year surgery-free survival

    Measured: From first dose of PD1/PDL1 antibody until the date of surgery, assessed up to 3 years

  6. 3 year disease free survival rate

    Rate of 3 year disease free survival

    Measured: From first dose of PD1/PDL1 antibody until disease progression (local or distant), secondary tumor or death (whichever occurs first), assessed up to 3 years

  7. 3 year overall survival rate

    Rate of 3 year overall survival

    Measured: From first dose of PD1/PDL1 antibody until death, assessed up to 3 years

  8. 5 year overall survival rate

    Rate of 5 year overall survival

    Measured: From first dose of PD1/PDL1 antibody until death, assessed up to 5 years

  9. 3 year local recurrence free survival rate

    Rate of 3 year local recurrence free survival

    Measured: From first dose of PD1/PDL1 antibody until first local failure or death (whichever occurs first), assessed up to 3 years

  10. 3 year distant metastasis free survival rate

    Rate of 3 year distant metastasis free survival

    Measured: From first dose of PD1/PDL1 antibody until distant metastasis or death (whichever occurs first), assessed up to 3 years

  11. 3 year surgery free survival rate

    Rate of 3 year surgery free survival

    Measured: From first dose of PD1/PDL1 antibody until radical surgery or death (whichever occurs first), assessed up to 3 years

  12. Treatment-related adverse event of combination of Sintilimab, IBI310 and Lenvatinib

    A treatment-related adverse event (TRAE) is defined as any adverse event not present prior to the initiation of drug treatment or any adverse event already present that worsens in intensity or frequency following exposure to the drug treatment. TRAEs were graded using National Cancer Institute (NCI)-CTCAE version 5.0.

    Measured: From first dose of Sintilimab, IBI310 and Lenvatinib to 30 days after last dose of treatment.

  13. Quality of life of combination of Sintilimab, IBI310 and Lenvatinib for gastric cancer patients

    Quality of life will be evaluated using EORTC QLQ-C30 and QLQ-STO22.

    Measured: From first dose of PD1/PDL1 antibody until death, assessed up to 8 years

  14. Quality of life of combination of Sintilimab, IBI310 and Lenvatinib for colon cancer patients

    Quality of life will be evaluated using EORTC QLQ-C30 and EORTC QLQ-CR29.

    Measured: From first dose of PD1/PDL1 antibody until death, assessed up to 8 years

  15. Rate of complications

    Rate of complications in perioperative period

    Measured: From 7 days before surgery to 12 days after surgey

  16. Rate of mortality

    Rate of mortality in perioperative period

    Measured: From 7 days before surgery to 12 days after surgey

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2024
  2. Study start13 Sep 2024
  3. Primary completion1 Jun 2029 (estimated)
  4. Study completion1 Jun 2029 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06580574
Sponsor's protocol ID
CGOG-IMAGINE-06
Status last verified
Apr 2026
First submitted
24 Aug 2024
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD1/PDL1 antibody monotherapy, up to 24 weeks, Intensive immunotherapy plus anti-VEGF treatment, up to 24 weeks and Radical surgery in people with Gastric Cancer and Colon Cancer, run by Peking University 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 10 inclusion and 10 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 15 May 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 Lin Shen (010-88196561, shenlin@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Organ preservation rate (time frame: The status of cCR or near-cCR and the possibility of organ preservation will be evaluated after completion of PD1/PDL1 antibody monotherapy, 12 weeks after Sintilimab, IBI310 and Lenvatinib, and 24 weeks after Sintilimab, IBI310 and Lenvatinib). 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 NCT06580574.

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 15 May 2026.

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