Using immunotherapy and chemotherapy for advanced gastric cancer treatment
Official title: Prospective Cohort Study on the Efficacy, Adverse Effects, and Biomarkers of First-Line/Neoadjuvant Therapy With Immune Checkpoint Inhibitors Combined With Chemotherapy in Advanced Gastric Cancer
Run by Qilu Hospital of Shandong University · NCT06727981 · Data updated 2026-11-12
This study is testing if combining immunotherapy with chemotherapy can help people with advanced gastric cancer feel better and improve their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | January 15, 2022 |
| Main results expected | January 15, 2027 |
| Study ends | January 15, 2028 |
| Registry record updated | December 11, 2024 |
| Trial ID | NCT06727981 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with advanced or locally advanced gastric cancer who have not undergone previous anti-tumor therapy.
✕Probably not a fit
Patients with contraindications to immunotherapy or those who have received prior anti-tumor treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study evaluates the efficacy and safety of immune checkpoint inhibitors combined with chemotherapy as first-line and neoadjuvant therapy for patients with advanced gastric cancer. The study also aims to investigate relevant biomarkers to enhance understanding of immunotherapy outcomes. Eligible participants include those who have not received prior anti-tumor therapy and are expected to receive immunotherapy. The study is conducted at Qilu Hospital of Shandong University in Jinan, Shandong.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced gastric cancer.
How similar studies have gone: Other studies have shown promise with similar immunotherapy approaches in treating gastric cancer, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years old or above 2. Patients with advanced gastric cancer or locally advanced gastric cancer 3. Have not received any previous anti-tumor therapy 4. Patients expected to receive immunotherapy for first-line or neoadjuvant therapy 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 6. Adequate organ function Exclusion Criteria: 1. Patients with contraindications to immunotherapy 2. Have received anti-tumor treatments such as immunotherapy and chemotherapy 3. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases 4. Severe chronic or active infection requires systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection. Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment 5. History of allogeneic stem cell transplantation or organ transplantation
Where it's running
-
Qilu Hospital of Shandong University
Jinan, Shandong, China Recruiting
Study contacts
- Principal investigator: Lian Liu, MD — Qilu Hospital of Shandong University
- Study coordinator: Lian Liu, MD
- Email: tounao@126.com
- Phone: 0531-82169851
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Predicting Immunotherapy Response in Advanced Gastric Cancer using PET Imaging
This study tests whether FAPI PET/CT and Grazytracer PET/CT can predict how advanced gastric cancer will respond to preoperative immunotherapy-based treatment.
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Adding 2141-V11 to standard therapy for advanced esophageal, gastric, or gastroesophageal junction cancer
This study tests whether adding the drug 2141-V11 to standard anti-PD-1 therapy (with or without 5-FU) is safe for adults with advanced or metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma.
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Low-leucine diet with chemotherapy and immunotherapy for advanced stomach cancer
This will test whether a low-leucine diet helps people with advanced gastric cancer respond better to combined chemotherapy and immunotherapy.
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BHB810 in advanced gastric and GEJ cancer (early-phase)
This study tests whether BHB810 can be safely given every two weeks to adults with advanced gastric or GEJ adenocarcinoma and looks at its effect, how the drug behaves in the body, and patient responses.
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Managing chemotherapy side effects with a smartphone symptom app plus telenursing
This trial tests whether a smartphone symptom-reporting app combined with a standardized telenursing program helps adults starting first-cycle chemotherapy for gastric, lung, breast, or colon cancer manage treatment side effects.
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QL1706 (Iparomlimab + Tuvonralimab) with SOX chemotherapy for untreated advanced or metastatic gastric or gastroesophageal junction cancer
This trial will test whether adding QL1706 (two immunotherapy drugs) to SOX chemotherapy helps people with previously untreated advanced or metastatic gastric or gastroesophageal junction cancer get a better tumor response.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.