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Gastroesophageal Junction AdenocarcinomaPhase 2NCT06739161

Sintilimab in Combination with Chemotherapy ± Local Treatment for Om-G/GEJ

A Phase 2 study testing Sintilimab combined with chemotherapy and local treatment and Sintilimab combined with chemotherapy only in people with Gastroesophageal Junction Adenocarcinoma, run by Jiangsu Cancer Institute & 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

Gastric cancer is one of the most common and deadly cancers globally, with poor prognosis. About 70% of patients are diagnosed at an advanced stage, and the median overall survival (OS) is only 3-4 months. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gastroesophageal Junction Adenocarcinoma
What is being tested?
Sintilimab combined with chemotherapy and local treatment and Sintilimab combined with chemotherapy only
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
2 Dec 2024to 2 Dec 2028
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed esophagogastric junction (EGJ)/gastric adenocarcinoma.
  • Oligometastatic disease diagnosed via CT, MRI, or PET/CT:≤3 extracranial organs involved, ≤5 total metastatic lesions, each ≤5 cm in diameter,Regional lymph nodes count as one station; distant nodes counted per station.
  • No progression after two cycles of immunochemotherapy.
  • Primary and metastatic lesions at diagnosis eligible for local treatment.
  • All metastatic lesions measurable per RECIST 1.1.
  • Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
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  • Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN in the absence of liver metastases, or < 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.
  • Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min.
  • Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN.
  • No serious concomitant disease that will threaten the survival of patients to less than 5 years.
  • Male or female. Age ≥ 18 years and ≤80 years.
  • Written (signed) informed consent.
  • Good compliance with the study procedures, including lab and auxiliary examination and treatment.
  • Female patients should not be pregnant or breast feeding.

Who cannot join

  • Non-adenocarcinoma histology of gastric/esophagogastric junction tumors, such as squamous cell carcinoma or neuroendocrine carcinoma.
  • Esophagogastric junction/gastric adenocarcinoma with positive Her-2 status requiring anti-Her-2 treatment.
  • Uncontrolled meningeal or peritoneal metastasis.
  • Peripheral neuropathy of grade ≥2.
  • Poor nutritional status, BMI <18.5 kg/m², or PG-SGA score ≥9.
  • Underwent major surgery or suffered a severe injury within 4 weeks prior to the first dose of the investigational drug.
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  • Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Received any investigational drug within 4 weeks prior to the first dose of the study drug.
  • Required systemic treatment with corticosteroids (daily >10 mg prednisone equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of the investigational drug.
  • Received an anti-tumor vaccine or live vaccine within 4 weeks before the first dose of the study drug.
  • Diagnosed with any active autoimmune disease or a history of autoimmune diseases.
  • History of immunodeficiency, including a positive HIV test, any acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
  • Any condition within 14 days prior to treatment requiring systemic corticosteroid therapy (dose>10mg/day of prednisone or equivalent) or other immunosuppressive treatments.
  • Presence of uncontrolled cardiac symptoms or conditions, such as:
  • NYHA Class II or higher heart failure
  • Unstable angina
  • Myocardial infarction within the past year
  • Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
  • Severe infection within 4 weeks prior to the first dose, including pneumonia requiring hospitalization, bacteremia, or infectious complications.
  • History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary diseases.
  • Active pulmonary tuberculosis infection diagnosed by history or CT scan, or a history of active tuberculosis infection within the past year, or a history of untreated active tuberculosis infection more than one year ago.
  • Active hepatitis B or hepatitis C.
  • Laboratory abnormalities of sodium, potassium, or calcium greater than Grade 1 within 2 weeks before enrollment that cannot be corrected with treatment.
  • Known allergy to monoclonal antibodies, any PD-1 components, paclitaxel, capecitabine, or any components used in their formulations.
  • Pregnant or breastfeeding women, or women of childbearing potential who are unwilling or unable to use effective contraception.

Trial locations and contacts

1 site in 1 country.

China1 site

  • ChengChen

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: A Phase II Randomized Controlled Trial of Sintilimab in Combination with Chemotherapy ± Local Treatment for Oligometastatic Esophagogastric Junction/Gastric Adenocarcinoma

Gastric cancer is one of the most common and deadly cancers globally, with poor prognosis. About 70% of patients are diagnosed at an advanced stage, and the median overall survival (OS) is only 3-4 months. Current treatments, including immune checkpoint inhibitors combined with chemotherapy, have slightly improved survival, but most patients still experience disease progression during treatment, and those with PD-L1 CPS ≤5 do not benefit from immunotherapy.

Local radiotherapy, as a palliative treatment, can alleviate symptoms like bleeding, dysphagia, and pain, improving quality of life. Studies show that it significantly improves progression-free survival and may extend overall survival when added to chemotherapy. Therefore, combining local radiotherapy with immunochemotherapy may offer additional survival benefits for patients with advanced gastric cancer.

Being tested
Sintilimab combined with chemotherapy and local treatment, Sintilimab combined with chemotherapy only

What participants receive

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

  • Sintilimab combined with chemotherapy and local treatmentRadiation

    Treatment Regimens

    ①Chemotherapy: Regimen follows guideline-recommended first-line therapy for advanced gastric cancer.

    ②Sintilimab (200 mg) is administered with chemotherapy every 21 days. Maintenance immunotherapy continues for up to 1 year after chemotherapy.

    ③Local Treatment: Performed during cycles 3-8 of immunochemotherapy. Radiotherapy is preferred, using a combination of high- and low-dose fractionation, tailored to tumor location, size, and proximity to critical organs.

    Alternative local treatments, such as radiofrequency ablation or surgery, may be used if suitable.

  • Sintilimab combined with chemotherapy onlyCombination product

    Treatment Regimens ①Chemotherapy: Regimen follows guideline-recommended first-line therapy for advanced gastric cancer.

    ②Sintilimab (200 mg) is administered with chemotherapy every 21 days. Maintenance immunotherapy continues for up to 1 year after chemotherapy.

Study groups in NCT06739161
Study groupRoleWhat they receive
Sintilimab combined with chemotherapy and local treatmentExperimental①Chemotherapy: Regimen follows guideline-recommended first-line therapy for advanced gastric cancer. ②Sintilimab (200 mg) is administered with chemotherapy every 21 days. Maintenance immunotherapy continues for up to 1 year after chemotherapy. ③Local Treatment : Performed during cycles 3-8 of immunochemotherapy. Radiotherapy is preferred, using a combination of high- and low-dose fractionation, tailored to tumor location, size, and proximity to critical organs.
Receives: Radiation: Sintilimab combined with chemotherapy and local treatment
Sintilimab combined with chemotherapyActive comparator①Chemotherapy: Regimen follows guideline-recommended first-line therapy for advanced gastric cancer. ②Sintilimab (200 mg) is administered with chemotherapy every 21 days. Maintenance immunotherapy continues for up to 1 year after chemotherapy.
Receives: Combination Product: Sintilimab combined with chemotherapy only

What is being measured

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

  1. Progression free survival, defined as the time from randomization to disease progression or death, whichever occurs first.

    Progression will be assessed based on imaging studies and clinical evaluation, using RECIST v1.1 criteria. Data will be summarized using Kaplan-Meier estimates, and hazard ratios will be calculated.

    Measured: From the date of randomization until tumor progression or death from any cause, whichever occurs first, assessed up to 24 months

Secondary outcomes (5)

  1. Overall Survival, defined as the time from randomization to death from any cause.

    Overall Survival will be assessed using Kaplan-Meier estimates and compared between groups using a log-rank test. Median survival and survival rates at specific time points will be reported.

    Measured: From the date of randomization until death from any cause, assessed up to 36 months

  2. Objective Response Rate, defined as the proportion of participants achieving a complete or partial response, as assessed by RECIST v1.1 criteria.

    Responses will be evaluated through imaging and clinical assessments, with data reported as a percentage along with corresponding 95% confidence intervals.

    Measured: From the date of randomization until the date of first documented objective response, assessed up to 12 months

  3. Time to Progression, defined as the time from randomization to the first documented disease progression, as assessed by RECIST v1.1 criteria.

    Time to Progression will exclude cases of death that occur without documented disease progression. Kaplan-Meier estimates will be used for analysis.

    Measured: From the date of randomization until the date of first documented progression, assessed up to 24 months

  4. Treatment Safety: Number of participants with treatment-related adverse events, as assessed by CTCAE v5.0.

    Treatment-related adverse events will be categorized based on their severity and relationship to treatment, with descriptive statistics used to summarize their frequency and types.

    Measured: From the date of randomization until the end of treatment, assessed up to 18 months

  5. Time to Symptom Deterioration, based on patient-reported outcomes using validated quality of life instruments (e.g., EORTC QLQ-C30).

    Time to Symptom Deterioration is defined as the time from randomization to the first clinically meaningful deterioration in symptom scores, determined by a predefined threshold. Kaplan-Meier methods will be used to analyze the data.

    Measured: From the date of randomization until the first documented symptom deterioration, assessed up to 12 months

Timeline

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

  1. First posted18 Dec 2024
  2. Study start2 Dec 2024
  3. Primary completion2 Dec 2027 (estimated)
  4. Study completion2 Dec 2028 (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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06739161
Sponsor's protocol ID
SCIR for G/GEJ
Status last verified
Dec 2024
First submitted
2 Dec 2024
Last updated
18 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 combined with chemotherapy and local treatment and Sintilimab combined with chemotherapy only in people with Gastroesophageal Junction Adenocarcinoma, run by Jiangsu Cancer Institute & 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 14 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: under way, not looking for participants, as of the sponsor's last update on 18 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 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?

Progression free survival, defined as the time from randomization to disease progression or death, whichever occurs first. (time frame: From the date of randomization until tumor progression or death from any cause, whichever occurs first, 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 NCT06739161.

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 Dec 2024.

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