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Overall Response RateNCT06277024

A Study on the Safety and Efficacy of the Combination of Candenizumab, Lenvatinib, and SOX Regimen in the Treatment of HER2 Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients

A study testing Combination of Cardonizumab with Lenvatinib and SOX regimen in people with Overall Response Rate, run by Fujian Medical 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
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Trial summary

Evaluate the objective response rate (ORR) of the combination of candenizumab, lenvatinib, and SOX regimen for the treatment of HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma patients Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Overall Response Rate
What is being tested?
Combination of Cardonizumab with Lenvatinib and SOX regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Jan 2023to 31 Dec 2027
Phase
Interventional
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

  • Age: 18 years ≤ Age ≤ 75 years;
  • Locally advanced or metastatic HER2 negative gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology or cytology that cannot be resected;
  • Has not received radiotherapy, chemotherapy, targeted therapy, or immunotherapy as the primary treatment option for advanced or metastatic diseases in the past; Participants with gastric or gastroesophageal junction adenocarcinoma who have previously received adjuvant or neoadjuvant chemotherapy, radiotherapy, and/or radiochemotherapy are eligible for enrollment as long as the last administration of the previous protocol occurred at least 6 months prior to randomization.
  • At least one measurable lesion #see Appendix 2#;
  • ECOG PS: 0-1 points #see Appendix 4#;
  • Estimated survival time>3 months;
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  • The main organ function is normal and meets the following criteria:
  • Blood routine examination must meet the following criteria#no blood transfusion within 14 days#
  • HB ≥ 100g/L,
  • WBC ≥ 3 × 109/L
  • ANC ≥ 1.5 × 109/L,
  • PLT ≥ 100 × 109/L;
  • Biochemical examination must meet the following standards:
  • BIL<1.5 times the upper limit of normal value #ULN#,
  • ALT and AST<2.5ULN, GPT ≤ 1.5 × ULN;
  • Serum Cr ≤ 1ULN, endogenous creatinine clearance rate>60ml/min #Cockcroft Gault formula#
  • Women of childbearing age must undergo a pregnancy test #serum# within 7 days before enrollment, and the result is negative. They are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the trial drug; For males, surgical sterilization or agreement to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the trial drug should be considered; 9# Not participating in other clinical studies before and during treatment; 10# The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.

Who cannot join

  • If a subject meets any of the following conditions, they will not be allowed to enter this study
  • Patients with allergies or suspected allergies to research drugs or similar drugs;
  • Suffering from other malignant tumors within the past 5 years, excluding skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
  • Received live vaccine within 4 weeks prior to enrollment or possibly during the study period;
  • Suffering from active autoimmune diseases or having a history of autoimmune diseases within 4 weeks prior to enrollment;
  • Previously received allogeneic bone marrow transplantation or organ transplantation;
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  • The patient currently has any disease or condition that affects drug absorption, or the patient is unable to take medication orally;
  • The patient currently has hypertension that cannot be controlled by medication, which is defined as: patients with hypertension who cannot be well controlled with a single antihypertensive drug treatment #systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100mmHg#; Or use two or more antihypertensive drugs to control blood pressure in patients;
  • Urinary routine indicates that urine protein is ≥ 2+, and the 24-hour urine protein volume is>1.0g;
  • The patient currently has digestive tract diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by the researcher that may cause gastrointestinal bleeding or perforation;
  • Patients with significant evidence of bleeding tendency or medical history within the 3 months prior to enrollment #bleeding>30 mL within 3 months, vomiting blood, black stool, and rectal bleeding#, hemoptysis #fresh blood>5 mL within 4 weeks#, or thromboembolic events #including stroke events and/or transient ischemic attacks# within 12 months;
  • Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting surgery within 6 months prior to enrollment; Congestive heart failure is classified by the New York Heart Association #NYHA# as>level 2; Ventricular arrhythmia requiring medication treatment; Electrocardiogram #ECG# shows a QT interval of ≥ 480 milliseconds;
  • Active or uncontrolled severe infection #≥ CTCAE level 2 infection#;
  • Known human immunodeficiency virus #HIV# infection; Known clinically significant history of liver disease, including viral hepatitis [known carriers of hepatitis B virus #HBV# must exclude active HBV infection, i.e. HBV DNA positivity #>1 × 104 copies/mL or>2000 IU/ml#; Known hepatitis C virus infection #HCV# and HCV RNA positivity #>1 × 103 copies/mL, or other types of hepatitis or cirrhosis;
  • According to the judgment of the researchers, patients deemed unsuitable for inclusion in this study.

Trial locations and contacts

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

China1 site, 1 recruiting

  • Department of Gastric Surgery， Fujian Medical University Union Hospital

    Fuzhou, Fujian

    Changming Huang, MD, +8613805069676, hcmlr2002@163.com

    Recruiting

Other trials in China

About this study

Evaluate the objective response rate (ORR) of the combination of candenizumab, lenvatinib, and SOX regimen for the treatment of HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma patients

Read the detailed description

Local advanced or metastatic HER2 negative gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology or cytology that cannot be resected, and has not received systemic treatment (including HER2 inhibitors) as the primary treatment for advanced or metastatic diseases in the past.

Evaluate the objective response rate (ORR) of the combination of candenizumab, lenvatinib, and SOX regimen for the treatment of HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma patients Median survival time (OS);

  • Progression free survival time (PFS);
  • Duration of relief (DOR); Evaluate the safety of this regimen in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma patients, including the incidence of adverse events (AE), severe adverse reactions (SAE), dose adjustment rate, and dose pause rate; Observe the changes in quality of life of patients with advanced gastric or gastroesophageal junction adenocarcinoma after treatment.
Being tested
Combination of Cardonizumab with Lenvatinib and SOX regimen
Keywords
gastric cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Combination of Cardonizumab with Lenvatinib and SOX regimenDrug

    Phase 1: Conduct a ramp up test on the dosage of lenvatinib according to the traditional 3+3 design; Phase 2: 6 cycles of treatment with candenizumab+lenvatinib+SOX regimen (Q3W); For patients who have not progressed, they will enter the third stage of maintenance treatment.

    Phase 3: Maintenance therapy with candenizumab, lenvatinib, and tigio (Q3W).

Study groups in NCT06277024
Study groupRoleWhat they receive
Treatment with combination of candenizumab, lenvatinib, and SOX regimenExperimentalNot described
Receives: Drug: Combination of Cardonizumab with Lenvatinib and SOX regimen

What is being measured

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

  1. ORR

    Overall Response Rate

    Measured: 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 posted26 Feb 2024
  2. Study start1 Jan 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06277024
Sponsor's protocol ID
FUGES-32
Status last verified
Feb 2024
First submitted
4 Feb 2024
Last updated
26 Feb 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 study testing Combination of Cardonizumab with Lenvatinib and SOX regimen in people with Overall Response Rate, run by Fujian Medical 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 17 inclusion and 15 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 26 Feb 2024. 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.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 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 NCT06277024.

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 26 Feb 2024.

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