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Gastroesophageal AdenocarcinomaPhase 2NCT06985602

Adebrelimab With Chemoradiotherapy and Surgery for G/GEJ

A Phase 2 study testing Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by Surgery in people with Gastroesophageal Adenocarcinoma and Gastric Adenocarcinoma, run by Jiangsu Cancer Institute & Hospital 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

Gastric cancer is one of the most common and deadly cancers globally, characterized by a poor prognosis. Approximately 70% of patients are diagnosed at an advanced stage, and the 5-year survival rate is only around 10%. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by Surgery
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
16 May 2025to 1 Jun 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.
  • Patients with locally advanced disease (AJCC staging T4b or N2 fusion metastasis) or limited metastasis confirmed by endoscopy, CT, MRI, or PET/CT scans, and multidisciplinary team (MDT) discussion.
  • From a medical and surgical technical perspective, the primary lesion and surrounding abdominal lymph nodes are assessed as potentially resectable; limited metastatic lesions are evaluated by MDT for resectability or for the possibility of achieving curative treatment through other local treatment methods (such as local radiotherapy or radiofrequency ablation).
  • Exclusion of peritoneal metastasis.
  • Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
  • 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.
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  • 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.
  • The primary lesion is considered unresectable from a medical or surgical technical perspective.
  • Imaging diagnosis indicates widespread metastasis (metastasis that does not meet the criteria for limited metastasis as defined above is considered widespread 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. Contact the study team or a site near you to ask about taking part.

Cheng Chen contact

+86-025-83283555

njmudoctor@163.com

China1 site, 1 recruiting

  • Jiangsu cancer hospital

    Nanjing, Province, 210009

    Cheng Chen, +86-025-83283555, njmudoctor@163.com

    Recruiting

Other trials in China

About this study

Official title: Adebrelimab Combined With Chemoradiotherapy Followed by Surgery for Locally Advanced or Limited Metastatic Gastric/ Esophagogastric Junction Adenocarcinoma.

Gastric cancer is one of the most common and deadly cancers globally, characterized by a poor prognosis. Approximately 70% of patients are diagnosed at an advanced stage, and the 5-year survival rate is only around 10%. While advancements in targeted therapies and immunotherapy have improved treatment efficacy and extended survival, advanced gastric and gastroesophageal junction adenocarcinomas remain incurable. Subgroup analyses indicate that patients with limited metastases, such as liver oligometastasis or retroperitoneal lymph node metastasis, may benefit more from conversion therapy. However, current guidelines do not recommend specific treatment protocols for gastric cancer with limited metastasis. Immunotherapy has shown moderate efficacy in selected patients with advanced gastric adenocarcinoma. Additionally, low-dose radiotherapy (LDRT) may synergistically enhance antitumor responses when combined with immunotherapy. This Phase II trial aims to evaluate the safety and efficacy of combining Adebrelimab, chemotherapy, and LDRT before surgery in treating adult patients with gastric or gastroesophageal junction adenocarcinoma.

Being tested
Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by Surgery

What participants receive

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

  • Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by SurgeryCombination product

    • Adebrelimab: Given concurrently with chemotherapy, 1200mg by intravenous infusion every three weeks for four cycles.
    • Chemotherapy: Oxaliplatin 130mg/m² on day 1 + Capecitabine 1000mg/m² bid (XELOX regimen), from day 1 to day 14, repeated every three weeks for four cycles;
    • Radiotherapy: Unresectable limited metastatic lesions with SBRT; Potentially resectable lesions with low-dose radiotherapy.
    • Surgery: Performed 3-5 weeks after the completion of conversion therapy.
Study groups in NCT06985602
Study groupRoleWhat they receive
Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by SurgeryExperimentalNot described
Receives: Combination Product: Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by Surgery

What is being measured

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

  1. Treatment Safety

    Treatment-related adverse events will be categorized by severity and relationship to treatment. Descriptive statistics will be used to summarize the frequency and types.

    Measured: From enrollment until the end of treatment, assessed up to 18 months.

Secondary outcomes (4)

  1. R0 Rate

    Defined as the proportion of patients who achieve complete resection with no tumor within 1 mm of the resection margins (R0), calculated by dividing the number of patients achieving R0 resection by the total number of evaluable patients.

    Measured: From the completion of conversion therapy until surgery, assessed within 8 weeks.. following treatment completion

  2. Pathologic complete response

    Defined as pT0N0M0

    Measured: From the completion of conversion therapy until surgery, assessed within 8 weeks following treatment completion

  3. Progression-Free Survival

    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 enrollment until tumor progression or death from any cause, whichever occurs first, assessed up to 2 years

  4. Overall Survival

    Overall Survival will be assessed using Kaplan-Meier estimates. Median survival and survival rates at specific time points will be reported.

    Measured: From enrollment until death from any cause, assessed up to 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 posted22 May 2025
  2. Study start16 May 2025 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06985602
Sponsor's protocol ID
GAS-Jiangsu03
Status last verified
May 2025
First submitted
15 May 2025
Last updated
22 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by Surgery in people with Gastroesophageal Adenocarcinoma and Gastric 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 13 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: looking for participants now, as of the sponsor's last update on 22 May 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?

Contact Cheng Chen (+86-025-83283555, njmudoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Safety (time frame: From enrollment until the end of treatment, assessed up to 18 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 NCT06985602.

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 22 May 2025.

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