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Unresectable/Metastatic Gastric CancerPhase 2NCT06365008

Sintilimab Plus FOLFIRI as Second-line Therapy for Patients With HER2-negative Advanced Gastric Cancer

A Phase 2 study testing Sintilimab+irinotecan+leucovorin folinate+fluorouracil in people with Unresectable/Metastatic Gastric Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The combination of immune checkpoint inhibitors and platinum containing dual drugs are more used as a first-line therapeutic approach for patients diagnosed with advanced gastric cancer for its superior efficacy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Unresectable/Metastatic Gastric Cancer
What is being tested?
Sintilimab+irinotecan+leucovorin folinate+fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
Jun 2026to Jun 2036
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

  • Metastatic or locally advanced, unresectable HER2-negative gastric adenocarcinoma confirmed by histology or cytology
  • Progression or toxicity intolerance of first-line treatment
  • Patients aged ≥ 18 years
  • ECOG score 0-2
  • Estimated life expectancy of at least 12 weeks
  • Adequate organ and bone marrow function, as follows: Hemoglobin ≥8g/dl, neutrophil absolute count ≥1000/μL, platelets ≥ 75,000 /μL,Total bilirubin ≤1.5 x upper limit of normal (ULN), alkaline phosphatase, aspartate aminotransferase (AST (SGOT) and alanine aminotransferase (ALT (SGPT)) ≤2.5 x ULN (if liver metastasis is present, ≤5 x ULN), Serum albumin≥2.8g/dl, Serum creatinine ≤1.5 x ULN or calculated creatinine clearance >50mL/min (calculated according to Cockcroft Gault formula)
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  • International Normalized Ratio (INR) or activated partial thromboplastin time (APTT) <1.5 x ULN (thromboembolic event must be ruled out if D-dimer is abnormal)
  • Negative pregnancy test not more than 7 days before enrollment,Pregnancy tests can only be omitted in women who do not have any reproductive potential (e.g., postmenopausal women, i.e. amenorrhea ≥2 years or prior hysterectomy or bilateral oophorectomy). Fertile women and men must consent to the use of appropriate contraception at the time of enrollment and during study participation for at least 3 months after the last treatment
  • Have sufficient understanding ability and be willing to sign written informed consent

Who cannot join

  • Pregnant and lactating women
  • The patient has experienced hyperprogression and immunotherapy related grade 3 or above adverse reactions during previous immunotherapy
  • Received antitumor chemotherapy or biotherapy within 28 days prior to the first use of the investigational drug, the total area of previous bone marrow radiation therapy exceeds 30%; the exception is that if it is not the target lesion, palliative radiotherapy is allowed, and the radiotherapy area must be less than 25% of the bone marrow area
  • Suffering from other malignant tumors within the past 5 years or simultaneously
  • Suffering from severe neurological and psychiatric disorders
  • Patients with uncontrolled or symptomatic brain metastases
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  • Patients with active autoimmune diseases
  • Immunosuppressive or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) within 14 days prior to initiation of study therapy
  • Allergies to investigational drugs or excipients
  • Hypertension that cannot be controlled by antihypertensive drugs, coronary heart disease, heart failure, and arrhythmia (QTcF prolongation,>450ms in males and>470ms in females)
  • Severe infection in the 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumoniaOral or intravenous administration of therapeutic antibiotics within 2 weeks prior to initiation of study treatment (patients receiving prophylactic antibiotics, for example, to prevent urinary tract infections or exacerbation of chronic obstructive pulmonary disease are eligible for study participation)
  • Patients with congenital or acquired immune deficiency (such as HIV infection)
  • Have received live attenuated vaccines within 28 days prior to initiation of study treatment, or are expected to require such vaccines during sintilimab treatment or within 60 days after the last administration of sintilimab

Trial locations and contacts

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

Qiong Yang, Doctor contact

13632341201

yangqiong05@126.com

Yajing Liu, Doctor contact

13631327315

liuyajing1030@126.com

China1 site

  • Sun Yat-sen Memorial Hospital,Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    Qiong Yang, Doctor, 13632341201, yangqiong05@126.com

    Yajing Liu, Doctor, 13631327315, liuyajing1030@126.com

Other trials in China

About this study

Official title: Sintilimab Plus FOLFIRI as Second-line Therapy for Patients With HER2-negative Advanced Gastric Cancer: a Prospective Single-arm Phase II Study

The combination of immune checkpoint inhibitors and platinum containing dual drugs are more used as a first-line therapeutic approach for patients diagnosed with advanced gastric cancer for its superior efficacy. However, there are no standard recommendations for subsequent treatment after progression on first-line therapy. Here, the investigators conduct this open-label, monocenter, single arm phase II study to evaluate whether sintilimab in combination with irinotecan, leucovorin folinate and fluorouracil can be the second-line therapy for patients diagnosed with HER2-negative unresectable or metastatic gastric cancer progression on first-line therapy. Patients participated in this study will receive sintilimab 3mg/kg for patients with body weight<60kg or 200mg for patients with body weight ≥ 60kg, plus irinotecan 180mg/m2 intravenous infusion, leucovorin folinate 400mg/m2 intravenous infusion and fluorouracil 400mg/m2 intravenous injection followed by 2400mg/m2 intravenous infusion for 48 hours, repeated every two weeks. The primary endpoint is 5-month progression-free survival (PFS) rate. The investigators estimated that 27 patients were necessary. Secondary endpoints include overall survival, progression-free survival, objective response rate, disease control rate and safety for unresectable or metastatic gastric cancer. Exploratory endpoint is to detect the baseline ctDNA level of patients before initial treatment.

Being tested
Sintilimab+irinotecan+leucovorin folinate+fluorouracil
Keywords
Sintilimab, FOLFIRI
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Sintilimab+irinotecan+leucovorin folinate+fluorouracilDrug

    sintilimab 3mg/kg for patients with body weight<60kg or 200mg for patients with body weight ≥ 60kg, plus irinotecan 180mg/m2 intravenous infusion, leucovorin folinate 400mg/m2 intravenous infusion and fluorouracil 400mg/m2 intravenous injection followed by 2400mg/m2 intravenous infusion for 48 hours, repeated every two weeks.

Study groups in NCT06365008
Study groupRoleWhat they receive
Sintilimab+irinotecan+leucovorin folinate+fluorouracilExperimentalsintilimab 3mg/kg for patients with body weight<60kg or 200mg for patients with body weight ≥ 60kg, plus irinotecan 180mg/m2 intravenous infusion, leucovorin folinate 400mg/m2 intravenous infusion and fluorouracil 400mg/m2 intravenous injection followed by 2400mg/m2 intravenous infusion for 48 hours, repeated every two weeks.
Receives: Drug: Sintilimab+irinotecan+leucovorin folinate+fluorouracil

What is being measured

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

  1. 5-month progression-free survival (PFS) rate

    The 5-month PFS rate refers to the proportion of patients who do not experience tumor progression or all-cause death at the 5-month time point following initial treatment

    Measured: Undergo imaging examination to evaluate efficacy every 8 weeks ±7 days

Secondary outcomes (5)

  1. Overall survival

    OS is defined as the time from study enrollment to the date of death due to any cause, assessed up to 60 months.

    Measured: From the date of enrollment to the date of death from any cause, assessed up to 60 months.

  2. Progression free survival

    PFS is defined as the time from study enrollment to the first documentation of disease progression or all-cause death, whichever occurs first, assessed up to 60 months.

    Measured: From the date of enrollment to the first documentation of disease progression or all-cause death, whichever occurs first, assessed up to 60 months.

  3. Objective response rate

    ORR is defined as the percentage of patients relative to the total of enrolled subjects who achieve a complete response (CR) or partial response (PR) based on CT or MRI scan images

    Measured: Undergo imaging examination to evaluate efficacy every 8 weeks ±7 days

  4. Disease control rate

    DCR is defined as the percentage of patients relative to the total of enrolled subjects who achieve a complete response (CR) , partial response (PR) or stable disease (SD) based on CT or MRI scan images

    Measured: Undergo imaging examination to evaluate efficacy every 8 weeks ±7 days

  5. Adverse Events

    Assessment of Safety and tolerance for sintilimab plus FOLFIRI as salvage therapy in patients with unresectable/metastatic gastric cancer, including incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.

    Measured: from the date of the first medicine to 28±7 days after the last medicine

Timeline

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

  1. First posted15 Apr 2024
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2036 (estimated)
  4. Study completionJun 2036 (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
Not applicable
Intervention model
Single group
Model description
Patients will receive sintilimab 3mg/kg for patients with body weight\<60kg or 200mg for patients with body weight ≥ 60kg, plus irinotecan 180mg/m2 intravenous infusion, leucovorin folinate 400mg/m2 intravenous infusion and fluorouracil 400mg/m2 intravenous injection followed by 2400mg/m2 intravenous infusion for 48 hours, repeated every two weeks.
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06365008
Sponsor's protocol ID
SYSKY-2024-210-04
Status last verified
Apr 2026
First submitted
10 Apr 2024
Last updated
18 Jun 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 Sintilimab+irinotecan+leucovorin folinate+fluorouracil in people with Unresectable/Metastatic Gastric Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 9 inclusion and 13 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: opening soon, as of the sponsor's last update on 18 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 Qiong Yang, Doctor (13632341201, yangqiong05@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-month progression-free survival (PFS) rate (time frame: Undergo imaging examination to evaluate efficacy every 8 weeks ±7 days). 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 NCT06365008.

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 Jun 2026.

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