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Gastric (Stomach) CancerPhase 2FDZL-GC003NCT06748508

Comparing the Efficacy of Sintilimab Plus Nab-POF Regimen, Sintilimab Plus XELOX Chemotherapy, and Lenvatinib, Sintilimab Plus XELOX Chemotherapy in the Treatment of HER2-negative, Metastatic Gastric Cancer

A Phase 2 study testing Sintilimab, oxalipaltin, 5FU,Nab-paclitaxel,lenvatinib in people with Gastric (Stomach) Cancer, run by Fudan University at 2 sites 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

This trial is a prospective, open, randomized, phase II clinical study. It compares the current first-line treatment for advanced gastric cancer in phase II clinical trials, with the best efficacy being the combination of orient-16 study with sintilimab and XELOX regimen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric (Stomach) Cancer
What is being tested?
Sintilimab, oxalipaltin, 5FU,Nab-paclitaxel,lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
2 sitesChina
Study dates
25 Dec 2024to 25 Dec 2027
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

  • Males or females aged over than 18 years
  • Histologically or cytologically confirmed gastric adenocarcinoma (including GEJ adenocarcinoma)
  • Presence of measurable lesions(RECIST 1.1)
  • Newly diagnosed patients; or patients with recurrence after surgery, who have been off adjuvant chemotherapy for at least 6 months and have not received any anti-cancer treatment within the past 6 months
  • ECOG PS score: 0-1
  • Expected survival over than 3 months
  • Normal major organ function or reserve, meeting the following criteria (determined by laboratory test data within 7 days (inclusive) before screening): HB ≥90 g/dL, ANC ≥1.5×109/L, PLT ≥100×109/L; BIL<1.5×ULN, ALT and AST <2.5×ULN, if with metastases to liver, then ALT, AST <5×ULN; serum Cr≤1×ULN, endogenous creatinine clearance >50 mL/min (calculated by CK formula), international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, if the subject is receiving anticoagulant therapy, PT should be within the intended range of the anticoagulant drug
  • Subjects who voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up

Who cannot join

  • Histopathological assessment of HER2 positivity (immunohistochemistry 3+ or immunohistochemistry 2+ and FISH positive)
  • Known dMMR/MSI-H
  • History of other malignant neoplasms within 3 years prior to enrollment, except for cured cervical carcinoma in situ or basal cell carcinoma
  • Presence of brain metastases to meninges
  • Malignant pleural or peritoneal effusion
  • Presence of gastrointestinal obstruction, gastrointestinal haemorrhage (fecaloccult blood +++ or higher), or perforation
Show all 25Show fewer
  • Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2, CD137, CTLA-4 antibodies, or any other antibody or drug specifically targeting T-cell co-stimulatory or checkpoint pathways
  • Subjects with active or history of autoimmune diseases that might relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disorder, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or high-risk patients (e.g., those requiring immunosuppression after organ transplant), except for those with vitiligo, psoriasis, alopecia, or Graves' disease that have not required systemic treatment within the past 2 years, or hypothyroidism requiring only thyroid hormone replacement therapy, or Type I diabetes mellitus requiring only insulin replacement therapy
  • Current interstitial lung disorder or pneumonia, pulmonary fibrosis, acute lung disorder, or radiation pneumonitis
  • Participation in other drug clinical studies within 4 weeks prior to the first dose (based on the use of investigational drug), except observational (non-interventional) clinical studies
  • Use of immunosuppressant drugs within 4 weeks prior to the first dose of study treatment, excluding nasal, inhaled, or other topical glucocorticoids or physiological doses of systemic glucocorticoids (i.e., no more than 10 mg/day of prednisone or equivalent dose of other glucocorticoids), or short-term (no more than 7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases
  • Receipt of live attenuated vaccines within 4 weeks prior to the first dose of study treatment or planned immunization during the study period. Note: Inactivated seasonal influenza vaccines for injection are allowed within 4 weeks prior to the first dose; however, live attenuated influenza vaccines are not allowed.
  • Major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment or anticipated need for major surgery (not related to this study) during the study treatment period.
  • History of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive), or other acquired or congenital immunodeficiency diseases, or history of organ transplant or stem cell transplant
  • Active chronic hepatitis B or active hepatitis C; hepatitis B virus carriers, but patients with stable hepatitis B viral loads after drug therapy (HBV DNA ≤ 200 IU/mL or copy number < 1000 copies/mL), and patients who have cleared hepatitis C virus (HCV RNA negative) are eligible for enrollment
  • Known active pulmonary tuberculosis
  • Patients with severe infection within 4 weeks before the first dose, or active infection requiring oral or vein antibiotic therapy within 2 weeks before the first dose
  • Symptomatic congestive cardiac failure (New York Heart Association Class II-IV) or symptomatic or poorly controlled arrhythmia
  • Uncontrolled hypertension (blood pressure systolic ≥160 mmHg or blood pressure diastolic ≥100 mmHg) despite standard treatment
  • Any arterial embolism event within 6 months before enrollment, including myocardial infarction, angina unstable, cerebrovascular accident, or transient ischemic attack
  • History of deep vein thrombosis, pulmonary embolism, or any other severe embolism within 3 months before enrollment (thrombosis originating from implanted venous access port or catheter, or superficial vein thrombosis is not considered as "severe" thromboembolism)
  • History of definite neurological or mental disorder: such as epilepsy, dementia, poor compliance, or peripheral nervous system disorders
  • Alcohol dependence or history of drug addiction or drug abuse within the past year
  • Pregnant or lactating women,women of childbearing potential who are not taking adequate contraception
  • Other acute or chronic disease, mental disorder, or laboratory test abnormality that might lead to the following results: increased risk associated with study participation or study drug administration, or interference with the interpretation of study results, and the investigator judges the patient to be ineligible for participation in this study.

Trial locations and contacts

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

Weijian Guo, Ph.D., M.D. contact

+86 021-64175590

guoweijian1@hotmail.com

China2 sites

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Wanjing Feng, Ph.D., M.D., 1915659989@qq.com

Other trials in China

About this study

Official title: A Multicenter, Prospective, Open-label, Randomized Controlled, Phase II Clinical Trial Comparing the Efficacy of Sintilimab Plus Nab-POF Regimen, Sintilimab Plus XELOX Chemotherapy, and Lenvatinib, Sintilimab Plus XELOX Chemotherapy in the Treatment of HER2-negative, Metastatic Gastric Cancer

This trial is a prospective, open, randomized, phase II clinical study. It compares the current first-line treatment for advanced gastric cancer in phase II clinical trials, with the best efficacy being the combination of orient-16 study with sintilimab and XELOX regimen. The purpose of this study is to evaluate whether adding anti-angiogenic drugs or chemotherapy drugs on the basis of two-drug chemotherapy regimen (XELOX regimen) and PD-1 monoclonal antibody can improve efficacy for advanced gastric cancer.

Being tested
Sintilimab, oxalipaltin, 5FU,Nab-paclitaxel,lenvatinib
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, oxalipaltin, 5FU,Nab-paclitaxel,lenvatinibDrug

    Also called xeloda

    Patients were randomized in a 1:1:1 ratio to three treatment groups: control group A: pembrolizumab combined with XELOX regimen, the regimen was repeated every 3 weeks, and tumor efficacy was evaluated every 2 treatment cycles. Group B: treatment regimen was pembrolizumab combined with Nab-POF regimen, the regimen was repeated every 2 weeks, and tumor efficacy was evaluated every 3 treatment cycles. Group C: treatment regimen was pembrolizumab combined with XELOX regimen and lenvatinib, the regimen was repeated every 3 weeks, and tumor efficacy was evaluated every 2 treatment cycles.

Study groups in NCT06748508
Study groupRoleWhat they receive
XELOX regimen plus sintilimabActive comparatorsintilimab 200mg ivgtt d1+oxaliplatin 130mg/m2 ivgtt d1+xeloda 1000mg/m2 bid po d1-14，q3w
Receives: Drug: Sintilimab, oxalipaltin, 5FU,Nab-paclitaxel,lenvatinib
Nab-POF regimen plus sintilimabExperimentalsintilimab (200mg for the first time, 100mg for the second time, in alteration) ivgtt d1+oxaliplatin 85mg/m2 ivgtt d1+Nab-paclitaxel 125 mg/m2 ivgtt d1+5FU 2.4g/m2 civ48h, q2w
Receives: Drug: Sintilimab, oxalipaltin, 5FU,Nab-paclitaxel,lenvatinib
XELOX regimen plus sintilimab plus lenvatinibExperimentalsintilimab 200mg ivgtt d1+oxaliplatin 130mg/m2 ivgtt d1+xeloda 1000mg/m2 bid po d1-14+lenvatinib 8mg(<60kg) or 12mg(≥60kg) po qd，q3w
Receives: Drug: Sintilimab, oxalipaltin, 5FU,Nab-paclitaxel,lenvatinib

What is being measured

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

  1. Objective response rate

    he proportion of patients whose tumor decrease to a certain size and remained for a certain period of time, including those with complete response (CR) and partial response (PR)

    Measured: the duration from the date of randomization to any documented tumor progression or death due to any cause，assessed up to 24 months

Secondary outcomes (3)

  1. Overall survival

    Measured: the duration from the date of randomization to the date of death due to any cause,assessed up to 48 months

  2. Progression-free survival time

    Measured: the duration from the date of randomization to any documented tumor progression or death due to any cause, assessed up to 48 months

  3. Disease control rate

    assessed based on the RECIST 1.1 criteria, including complete response, partial response, and stable disease

    Measured: the duration from the date of randomization to any documented tumor progression or death due to any cause, assessed up to 24 months

Timeline

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

  1. First posted27 Dec 2024
  2. Study start25 Dec 2024 (estimated)
  3. Primary completion25 Jul 2027 (estimated)
  4. Study completion25 Dec 2027 (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
141 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06748508
Sponsor's protocol ID
MGC-NabPOF
Acronym
FDZL-GC003
Status last verified
Dec 2024
First submitted
3 Dec 2024
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
Yes
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, oxalipaltin, 5FU,Nab-paclitaxel,lenvatinib in people with Gastric (Stomach) Cancer, run by Fudan University at 2 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 8 inclusion and 25 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 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 Weijian Guo, Ph.D., M.D. (+86 021-64175590, guoweijian1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: the duration from the date of randomization to any documented tumor progression or death due to any cause，assessed up to 24 months). 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 NCT06748508.

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 27 Dec 2024.

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