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Gastric CancerPhase 2NCT05177068

Conversion Therapy of Fruquintinib in Combination With Sintilimab and SOX in Unresectable Gastric Cancer

A Phase 2 study testing fruquintinib + sintilimab + SOX in people with Gastric Cancer, run by Henan Cancer Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a phase II study to evaluate the efficacy and safety of combination of fruquintinib (VEGFR 1/2/3 inhibitor), sintilimab (PD-1 inhibitor) and SOX conversion therapy in unresectable advanced gastric cancer patients. 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?
fruquintinib + sintilimab + SOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
13 May 2022to 31 Dec 2025
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 the Informed Consent Form
  • Ages: 18-75 Years (concluding 18 and 75 Years)
  • Pathologically confirmed gastric/gastroesophageal junction adenocarcinoma, and meets one of the following conditions: invasion of adjacent organs such as colon, tail of pancreas and spleen; localized peritoneal metastasis; positive exfoliative cytology of ascites; class I, class II, part of class III and very few class IV stage IV gastric adenocarcinoma according to biological behavior; N3; extensive or fused lymph node metastasis; Krukenberg tumor; Liver metastasis limited to one lobe, less than 5cm in diameter, isolated abdominal aortic metastasis, etc;
  • Untreated(e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
  • Life expectancy greater than 3 months
  • ECOG(Eastern Cooperative Oncology Group) :0~1
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  • Sufficient organ and bone marrow functions as follows:
  • Absolute Neutrophil Count (ANC) ≥1.5×109/L, White Blood Cell≥3.5×109/L;
  • Platelet Count of ≥100×109/L;
  • Hemoglobin≥90g/L;
  • Total Bilirubin (TBIL) ≤1.5 x ULN;
  • ALT and AST<2.5 x ULN, GPT≤1.5×ULN; If there is liver metastasis, then ALT and AST<5.0 x ULN, GPT≤3.0×ULN;
  • Serum Creatinine (SCr) ≤1.0×ULN;
  • Endogenous creatinine clearance rate > 60ml / min (Cockcroft Gault formula);
  • No severe dysfunction of heart, lung and liver; No jaundice and gastrointestinal obstruction; No acute infection
  • Not participating in other clinical trials 4 weeks before and during the treatment

Who cannot join

  • Known HER-2 positive
  • Distal metastasis to lung, brain, and bone
  • Have received operation on the stomach
  • A history of other malignancies within 5 years prior to inclusion, except for cervical carcinoma in situ, basal or squamous cell skin cancer
  • Patients with any active autoimmune disease or a documented history of autoimmune disease within 4 weeks prior to enrollment
  • Previously received allogeneic bone marrow transplantation or organ transplantation
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  • Known hypersensitivity to any of the study drugs or excipients
  • Hypertension that is not controlled by the drug, and is defined as: SBP ≥150 mmHg and/or DBP ≥90 mmHg
  • International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN
  • Poorly controlled diabetes before enrollment
  • Clinically significant electrolyte abnormalities judged by researchers
  • With any diseases or conditions that affected drug absorption, or the patient could not take drugs orally
  • Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment, hemoptysis or thromboembolism within 12 months
  • Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) < 50%
  • Active infection or serious infection that is not controlled by drug (≥CTCAE v5.0 Grade 2）
  • History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×104/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×103/m)
  • Women who are pregnant or lactating
  • Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0 g
  • Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions which, according to judgement of the investigator, renders the patient inappropriate for using of the investigational product or may affect interpretation of study results
  • Patients considered unsuitable for inclusion in this study by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Henan Tumor Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A Phase II Clinical Study of Fruquintinib Combined With Sintilimab and SOX as Conversion Therapy of Potentially Resectable Stage IV Gastric Cancer

This is a phase II study to evaluate the efficacy and safety of combination of fruquintinib (VEGFR 1/2/3 inhibitor), sintilimab (PD-1 inhibitor) and SOX conversion therapy in unresectable advanced gastric cancer patients.

Read the detailed description

Eligible patients will be given 3 or 6 cycles of combined therapy of fruquintinib + sintilimab + SOX. Then the patients evaluated resectable will be given one additional cycle of combined treatment with sintilimab + SOX, followed by R0 resection. If evaluated unresectable after 6 cycles of combination therapy, the patient will be given palliative first-line treatment. Adjuvant treatment with SOX regimen will be started 4 weeks after R0 resection for a total of 8 cycles in the perioperative period.

Conditions
Gastric Cancer
Being tested
fruquintinib + sintilimab + SOX
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • fruquintinib + sintilimab + SOXDrug

    fruquintinib: 4mg/d, qd po, d1-14, q3w; sintilimab: 200 mg/d, IV d1, q3w; S-1: BSA<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w; oxaliplatin: 130mg/m2, ivgtt 2-6h, d1, q3w

Study groups in NCT05177068
Study groupRoleWhat they receive
ExperimentalExperimentalfruquintinib + sintilimab + SOX (S-1 + oxaliplatin)
Receives: Drug: fruquintinib + sintilimab + SOX

What is being measured

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

  1. Surgical complete resection rate (R0)

    This is a complete macroscopic resection of the gross tumor with negative surgical margins

    Measured: about 3 years

Secondary outcomes (8)

  1. Rate of downstaging

    To determine the rate of downstaging of locally advanced cT3-4 and/or N+ gastric carcinomas after preoperative therapy

    Measured: about 3 years

  2. Pathological complete response (pCR) rate

    pCR is defined as the absence of residual tumor based on evaluation of the resected esophagogastric specimen according to Becker remission criteria

    Measured: about 3 years

  3. Major pathological response (MPR)

    MPR is defined as less than 10% residual tumor after neoadjuvant therapy

    Measured: about 3 years

  4. Objective Response Rate (ORR)

    ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment.

    Measured: about 3 years

  5. Event-free survival (EFS)

    Event-free survival (EFS) is defined as the time from treatment initiation until the occurrence of any predefined event, including disease progression preventing planned surgery, local or distant recurrence, or death from any cause.

    Measured: about 3 years

  6. Overall survival (OS)

    Overall survival (OS) [time frame: from the initial date of neoadjuvant therapy to the date of death due to any cause. Patients without documentation of death at the time of analysis will be censored at the last follow-up date]. Estimated using Kaplan-Meier method.

    Measured: about 3 years

  7. adverse event (AEs)

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

    Measured: about 3 years

  8. R0 Surgical Conversion Rate

    R0 Surgical Conversion Rate is defined as the proportion of R0 resections among patients who completed planned conversion therapy and underwent surgical exploration.

    Measured: about 3 years

Timeline

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

  1. First posted4 Jan 2022
  2. Study start13 May 2022
  3. Primary completion16 Oct 2024
  4. Study completion31 Dec 2025 (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
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05177068
Sponsor's protocol ID
HMPL-013-FLAG-G103
Status last verified
Feb 2025
First submitted
15 Dec 2021
Last updated
2 Oct 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fruquintinib + sintilimab + SOX in people with Gastric Cancer, run by Henan Cancer Hospital 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 16 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical complete resection rate (R0) (time frame: about 3 years). 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 NCT05177068.

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 Oct 2025.

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