Gastric AdenocarcinomaPhase 2NCT06808971
Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur (AOS) for Perioperative Treatment of Locally Advanced Resectable GC/GEJ
A Phase 2 study testing Adebrelimab, Nab-paclitaxel, Oxaliplatin, Tegafur Gimeracil Oteracil Potassium Capsule in people with Gastric Adenocarcinoma and Gastro-esophageal Junction Adenocarcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is a single-arm, prospective, phase II clinical trial. The patients are diagnosed with resectable locally advanced (cT3-4N+M0) gastric adenocarcinoma and esophageal gastric adenocarcinoma that had not been treated before. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma
- What is being tested?
- Adebrelimab, Nab-paclitaxel, Oxaliplatin, Tegafur Gimeracil Oteracil Potassium Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2025to 31 Dec 2027
- Phase
- Phase 2
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
- Patients voluntarily participate in this study and sign informed consent forms;
- 18-75 years old;
- Patients whose tumor has been pathologically diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, and has not received any type of antitumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);
- Confirmed TNM staging by CT or MRI as resectable cT3-4N+M0;
- ECOG score is 0-1;
- Patients who are able to swallow pills and capsules normally;
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- Patients whose expected survival period is longer than 12 weeks;
- The function of important organs meets the following requirements:
- Absolute number of neutrophils (ANC) ≥1.5×10^9/L B. Platelet number ≥90×10^9/L; C. Hemoglobin ≥90g/L; D.Total bilirubin ≤1.5×ULN; ALT, AST and/or AKP≤2.5×ULN; E. Serum creatinine ≤1.5×ULN or creatinine clearance rate >60mL/min (Cockcroft-Gault); F. Activated partial thromboplastin time (APTT) and international standardization ratio (INR) ≤1.5×ULN (for anticoagulation treatments using stable doses such as low-molecular heparin or warfarin and INR can be screened within the expected treatment range of anticoagulants); 9. Female patients with fertility must undergo a blood pregnancy test within 72 hours before the first administration of the drug and the result is negative. During the study period and at least 6 months after the last dose of the study drug, a medically approved contraceptive measure (such as intrauterine birth control device, contraceptive pill or condom) must be used; for men, it should be surgery, sterilization, or agree to use effective contraception during the study period and within 6 months after the last dose of the study drug.
Who cannot join
- Patients who are known to have peritoneal metastasis or positive peritoneal lavage cytology (CY1P0) or have distant metastasis;
- Patients whose tumor can not be resected by surgery for tumor reasons or comorbidity or patients who refuse to undergo surgery;
- Patients who have other malignant tumors within the past 5 years or at the same time, except for cured skin basal cell carcinoma, cervical in situ and breast cancer in situ;
- The toxicity of previous anti-tumor treatment has not recovered to CTCAE≤grade one (NCI CTCAEv5.0), except for hair loss (any level allowed) and peripheral neuropathy (need to be ≤grade two );
- Active bleeding;
- Patients who had gastrointestinal perforation, abdominal abscess or recent intestinal obstruction or imaging and clinical symptoms with intestinal obstruction in the past 3 months;
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- Uncontrollable hypertension, symptomatic cardiac insufficiency, and severe heart disease within 6 months, including but not limited to:
- Acute coronary syndrome; (2) Arrhythmias that require drug treatment or have clinical significance, or do not interrupt the use of drugs that may lead to QT prolongation during the research period; (3) Acute myocardial infarction; (4) Heart failure; (5) Any other heart disease judged by the researchers to be unsuitable for participating in this trial.
- 8. Patients who have active ulcers, unhealed wounds or fractures; 9. Patients who need antimicrobial treatment in the stage of active infection; 10. Active hepatitis (Hepatitis B reference: HBsAg positive and HBV DNA ≥500IU/ml; hepatitis C reference: HCV antibody positive and HCV virus copy number > normal value upper limit); 11. Patients with congenital or acquired immunodeficiency; 12. Patients who are planning to receive or have previously received organ or allogeneic bone marrow transplantation; 13. At present, patients who are accompanied by interstitial pneumonia or interstitial lung disease, or who have a previous history of interstitial pneumonia or interstitial lung disease that require hormone treatment, or other patients who may interfere with the judgment and treatment of immune-related pulmonary toxicity, fibrosis, organic pneumonia (such as occlusion bronchiolitis), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or screening CT showing active pneumonia or severe pulmonary function impairment; active pulmonary tuberculosis; 14. Patients with any active autoimmune diseases or a history of autoimmune diseases with the possibility of recurrence [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients who can only be controlled by hormone replacement therapy can be included in the group)]; patients with skin diseases that do not require systemic treatment, such as leukoplakia, psoriasis, hair loss, patients with type I diabetes that can be controlled by insulin treatment or have a history of asthma, but who have been completely relieved in childhood and do not require any intervention can be included in the group; asthma patients who need the intervention of bronchodilators cannot be included in the group; 15. Patients who are using immunosuppressive drugs or systemic corticosteroid treatment within 7 days before joining in the group to achieve the purpose of immunosuppression (>10mg/day of prednisone or other equivalent drugs); 16. Patients who have received live attenuated vaccine within 28 days before joining in the group, or need to inject such vaccines during treatment or within 60 days after the last dose; 17. Oral or intravenous antibiotics or intravenously within 4 weeks before joining the group (except for preventive antibiotics administered intravenously for no more than 48 hours); 18. Known allergies to any study drugs or excipients; 19. Participated in clinical research of other drugs 4 weeks before joining in the group; 20. Lactating women; 21. According to the researcher's judgment, the patient has other factors that may affect the research results or cause the forced termination of this study, such as alcoholism, drug abuse, other serious diseases (including mental illness that need combined treatment, and serious laboratory examination abnormalities, accompanied by family or social factors, which will affect the safety of patients);
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
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
LIN YANG, Doctor, linyangcicams@126.com
LIN YANG, Doctor
About this study
Official title: A Phase II Clinical Trial of Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur Gimeracil Oteracil Potassium Capsule for Perioperative Treatment of Locally Advanced Resectable Gastric/Gastroesophageal Adenocarcinoma
This study is a single-arm, prospective, phase II clinical trial. The patients are diagnosed with resectable locally advanced (cT3-4N+M0) gastric adenocarcinoma and esophageal gastric adenocarcinoma that had not been treated before.
After signing the informed consent form, patients will be screened for the study treatment of Adebrelimab combined with AOS. After 2 cycles of treatment, MDT assessments before surgery will be carried out. Patients with no disease progression will receive one more cycle of treatment before surgery. For patients who have undergone radical surgery, they will continue to receive 3 cycles of the immunochemotherapy after the operation (a total of 6 cycles of combined treatment before and after surgery), followed by Adebrelimab single treatment for up to a year (16 cycles).
Patients whose disease progressed that can not be surgically removed after preoperative treatment will be treated by the oncology physicians according to clinical routines.
Read the detailed description
This study is a single-arm, single-center, prospective, phase II clinical trial. The study subjects are patients with resectable locally advanced (cT3-4N+M0) gastric adenocarcinoma and esophageal gastric adenocarcinoma that had not been treated before.
A team of doctors, which includes the oncology physicians, surgeons and radiologists, will be in charge of the response assessment every two cycles of the study treatment. Then they will together decide whether the patient can receive radical surgery.
After signing the informed consent form, patients will be screened for the study treatment of Adebrelimab combined with AOS. After 2 cycles of treatment, MDT assessments before surgery will be carried out. Patients with no disease progression will receive one more cycle of treatment before surgery. For patients who have undergone radical surgery, they will continue to receive 3 cycles of the immunochemotherapy after the operation (a total of 6 cycles of combined treatment before and after surgery), followed by Adebrelimab single treatment for up to a year (16 cycles).
Patients whose disease progressed that can not be surgically removed after preoperative treatment will be treated by the oncology physicians according to clinical routines.
Safety follow-up: D1 per treatment cycle, before surgery, 30 days after the last study treatment.
Disease progression follow-up: every 2 treatment cycles (6 weeks) before the surgery. Every 3 months after the surgery for 2 years. Every 6 months after the surgery for 2 to 5 years, and once a year after five years.
Survival follow-up: Since the last cycle of treatment, it is carried out every three months until the patient died, missed or withdrew from the study.
- Being tested
- Adebrelimab, Nab-paclitaxel, Oxaliplatin, Tegafur Gimeracil Oteracil Potassium Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab, Nab-paclitaxel, Oxaliplatin, Tegafur Gimeracil Oteracil Potassium CapsuleDrug
Adebrelimab combined with Nab-paclitaxel, Oxaliplatin andTegafur Gimeracil Oteracil Potassium Capsule
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab, Nab-paclitaxel, Oxaliplatin, Tegafur Gimeracil Oteracil Potassium Capsule | Experimental | Adebrelimab combined with Nab-paclitaxel, Oxaliplatin and Tegafur Gimeracil Oteracil Potassium Capsule Receives: Drug: Adebrelimab, Nab-paclitaxel, Oxaliplatin, Tegafur Gimeracil Oteracil Potassium Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response rate (pCR)
The percentage of patients who undergone surgery with tumor regression grade of class one, which there is no tumor cell residue in the tumor lesions.
Measured: At the time of pathological diagnosis
Secondary outcomes (3)
Event Free Survival (EFS)
From the beginning of the study treatment to the first occurrence of any of the following events: disease progression, local or distant recurrence and metastasis, death, etc.
Measured: From the time of the first study treatment to the first occurrence of any of the following events: disease progression, local or distant recurrence and metastasis, death, etc.
major pathological response rate (MPR)
The percentage of patients with TRG grade two, which the tumor residues are rare in tumor lesions.
Measured: At the time of pathological diagnosis
Treatment safety
The adverse events occur during the study treatment, including that occurs during the immunochemotherapy and the surgery.
Measured: Recording the adverse events occurs from the time of the first dose of study treatment to 30 days after the last medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start28 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIN YANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- LIN YANG, Doctor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808971
- Sponsor's protocol ID
- NCC5105
- Status last verified
- Apr 2026
- First submitted
- 25 Jan 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No