Gastric CancerPhase 2NCT06475417
Neoadjuvant Adebrelimab + DOS in Locally Advanced Resectable Gastric Cancer
A Phase 2 study testing Adebrelimab combined with DOS in people with Gastric Cancer, run by Tang-Du Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of adebrelimab combined DOS in neoadjuvant treatment of locally advanced resectable gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Adebrelimab combined with DOS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2024to 26 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Participants will be recruited voluntarily and will provide informed consent before enrollment. They are expected to demonstrate good compliance and willingness to adhere to the study protocol, including attending follow-up visits as required.
- Inclusion criteria for participant eligibility are as follows:
- 1）Age between 18 and 75 years, with no gender restrictions. 2）Histopathological confirmation of locally advanced gastric or gastroesophageal junction adenocarcinoma obtained through gastric endoscopic biopsy.
- 3）Clinical staging consistent with T2-3N+M0 or T4aNanyM0, confirmed by imaging (CT/MRI) and endoscopic ultrasound.
- 4）Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 5）Expected survival of at least 12 weeks. 3.Prior to treatment initiation, participants must meet the following criteria related to vital organ function within the preceding 7 days:
- Hematological parameters: Hemoglobin (Hb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, Platelets (PLT) ≥ 80 × 10^9/L (no recent blood transfusions within 14 days).
Show all 10Show fewer
- Biochemical parameters: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 × ULN, Serum creatinine (Cr) ≤ 1.5 × ULN or Creatinine clearance rate (CCr) ≥ 60 ml/min.
- Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).
- 4.Female participants of childbearing potential must agree to use effective contraception during the study and for 6 months after the end of the study period. They must provide negative serum or urine pregnancy tests within 7 days before enrollment and must not be lactating. Male participants must also agree to use effective contraception during the study and for 6 months following its conclusion.
- 5.All participants must provide voluntary informed consent before participation in the study.
Who cannot join
- History of malignancies within the past 5 years, excluding cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors.
- Patients with tumors invading adjacent organs (e.g., aorta or trachea), posing a high risk of bleeding or fistula formation.
- Subjects requiring systemic treatment with corticosteroids (>10 mg prednisone or equivalent daily) or other immunosuppressive agents within 14 days prior to study treatment initiation, except for those with no active autoimmune disease who may receive inhaled or topical corticosteroids at doses equivalent to >10 mg prednisone daily or adrenal replacement steroid doses.
- Patients with significant malnutrition requiring intravenous nutrition or continuous infusion therapy requiring hospitalization. Patients with well-controlled nutrition for ≥28 days before randomization may be included.
- Participants receiving live vaccines/attenuated vaccines within 30 days after the first treatment.
- Unresolved toxicities of grade ≥4 as per CTCAE 4.02 due to previous treatments, excluding alopecia and ≤grade 2 neuropathy caused by oxaliplatin.
Show all 13Show fewer
- Allergic reactions or contraindications to any study drug components.
- Patients with severe and/or uncontrolled diseases, including hypertension, myocardial ischemia or infarction, arrhythmias, congestive heart failure, severe or uncontrolled diseases or active infections, renal failure, immunodeficiency diseases, poorly controlled blood glucose, seizures, history of interstitial lung disease, pulmonary fibrosis, or any condition interfering with the detection and management of suspected drug-related toxicities.
- Patients with current gastrointestinal diseases such as intestinal obstruction or those at risk of gastrointestinal bleeding, perforation, or obstruction.
- Patients who have undergone surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to enrollment.
- Patients with any bleeding events of grade ≥3 per CTCAE within 4 weeks before enrollment, or those with unhealed wounds, ulcers, or fractures.
- Participants with thrombotic events (arterial or venous) within 3 months, such as cerebrovascular accidents, deep vein thrombosis, or pulmonary embolism.
- Subjects planning to undergo or who have previously undergone allogeneic organ or bone marrow transplantation, including liver transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shannxi, 710038
Nan Wang, Dr, 15719286297, wangnandoc@163.com
About this study
Official title: Phase II Study of Neoadjuvant Adebrelimab, Docetaxel, Oxaliplatin, and S-1 in Patients With Resectable Advanced Gastric Cancer
To evaluate the efficacy and safety of adebrelimab combined DOS in neoadjuvant treatment of locally advanced resectable gastric cancer.
Read the detailed description
This prospective, single-center, single-arm clinical trial aims to enroll 42 treatment-naïve patients diagnosed with locally advanced gastric adenocarcinoma who are deemed operable. Following informed consent, patients will undergo screening to confirm eligibility. Subsequently, eligible participants will receive the standard dosage of Adebrelimab in combination with the DOS regimen for three cycles as neoadjuvant therapy prior to surgery. Within 3-6 weeks after completing the third cycle, preoperative imaging will be conducted to assess the efficacy of the novel neoadjuvant treatment and feasibility of achieving radical D2 resection. Patients will then undergo radical surgical resection for gastric cancer, with pathological complete response (pCR) being observed.
- Conditions
- Gastric Cancer
- Being tested
- Adebrelimab combined with DOS
- Keywords
- Gastric Cancer, Resectable, Neoadjuvant, ICIs
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab combined with DOSDrug
After signing the informed consent, they are screened to meet the inclusion criteria. After receiving the standard dose of adebrelimab combined with DOS regimen for 3 courses of treatment before surgery, and within 3-6 weeks after the completion of the third administration, preoperative imaging examination is used to evaluate the efficacy of new adjuvant treatment and the possibility of radical D2 resection, The patient underwent radical surgical treatment for gastric cancer and observed pCR
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab combined with DOS | Experimental | After signing the informed consent, they are screened to meet the inclusion criteria. After receiving the standard dose of adebrelimab combined with DOS regimen for 3 courses of treatment before surgery, and within 3-6 weeks after the completion of the third administration, preoperative imaging examination is used to evaluate the efficacy of new adjuvant treatment and the possibility of radical D2 resection, The patient underwent radical surgical treatment for gastric cancer and observed pCR. Receives: Drug: Adebrelimab combined with DOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate（pCR）
Pathological complete response rate according to Becker standard
Measured: 7 days after surgery
Secondary outcomes (7)
Major pathologic response (MPR)
MPR is defined as less than 10% residual viable tumor after neoadjuvant therapy.
Measured: 7 days after surgery
Disease-free survival（DFS）
The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer
Measured: Long term follow-up will continue until the death of the subject or the end of the study, at least three years
R0 resection rate
Proportion of R0 level surgery performed.
Measured: postoperative 6 hours
Overall Survival（OS）
Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause).
Measured: Long term follow-up will continue until the death of the subject or the end of the study, at least three years
Objective response rate（ORR）
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response.
Measured: 7 days before surgery
Event-free survival（EFS）
The length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay.
Measured: Preoperative progression, postoperative recurrence, and death from any cause
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Adverse reactions to chemotherapy and immunotherapy were graded according to the NCI-CTCAE4.0 grading criteria
Measured: Long term follow-up will continue until the death of the subject or the end of the study, at least three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start24 May 2024
- Primary completion20 May 2025 (estimated)
- Study completion26 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475417
- Sponsor's protocol ID
- 202404-05
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant Adebrelimab, Docetaxel, Oxaliplatin, and S-1 in Patients With Resectable Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06475417
- Acronym / sponsor ID
- 202404-05
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Resectable, Neoadjuvant, ICIs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 24 May 2024 (actual)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 26 Apr 2026 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of adebrelimab combined DOS in neoadjuvant treatment of locally advanced resectable gastric cancer.
Detailed description
This prospective, single-center, single-arm clinical trial aims to enroll 42 treatment-naïve patients diagnosed with locally advanced gastric adenocarcinoma who are deemed operable. Following informed consent, patients will undergo screening to confirm eligibility. Subsequently, eligible participants will receive the standard dosage of Adebrelimab in combination with the DOS regimen for three cycles as neoadjuvant therapy prior to surgery. Within 3-6 weeks after completing the third cycle, preoperative imaging will be conducted to assess the efficacy of the novel neoadjuvant treatment and feasibility of achieving radical D2 resection. Patients will then undergo radical surgical resection for gastric cancer, with pathological complete response (pCR) being observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab combined with DOS | Experimental | Drug: Adebrelimab combined with DOSAfter signing the informed consent, they are screened to meet the inclusion criteria. After receiving the standard dose of adebrelimab combined with DOS regimen for 3 courses of treatment before surgery, and within 3-6 weeks after the completion of the third administration, preoperative imaging examination is used to evaluate the efficacy of new adjuvant treatment and the possibility of radical D2 resection, The patient underwent radical surgical treatment for gastric cancer and observed pCR. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants will be recruited voluntarily and will provide informed consent before enrollment. They are expected to demonstrate good compliance and willingness to adhere to the study protocol, including attending follow-up visits as required.
- Inclusion criteria for participant eligibility are as follows:
- 1）Age between 18 and 75 years, with no gender restrictions. 2）Histopathological confirmation of locally advanced gastric or gastroesophageal junction adenocarcinoma obtained through gastric endoscopic biopsy.
- 3）Clinical staging consistent with T2-3N+M0 or T4aNanyM0, confirmed by imaging (CT/MRI) and endoscopic ultrasound.
- 4）Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 5）Expected survival of at least 12 weeks. 3.Prior to treatment initiation, participants must meet the following criteria related to vital organ function within the preceding 7 days:
Key exclusion criteria (13 listed)
- History of malignancies within the past 5 years, excluding cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors.
- Patients with tumors invading adjacent organs (e.g., aorta or trachea), posing a high risk of bleeding or fistula formation.
- Subjects requiring systemic treatment with corticosteroids (>10 mg prednisone or equivalent daily) or other immunosuppressive agents within 14 days prior to study treatment initiation, except for those with no active autoimmune disease who may receive inhaled or topical corticosteroids at doses equivalent to >10 mg prednisone daily or adrenal replacement steroid doses.
- Patients with significant malnutrition requiring intravenous nutrition or continuous infusion therapy requiring hospitalization. Patients with well-controlled nutrition for ≥28 days before randomization may be included.
- Participants receiving live vaccines/attenuated vaccines within 30 days after the first treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adebrelimab combined with DOSAfter signing the informed consent, they are screened to meet the inclusion criteria. After receiving the standard dose of adebrelimab combined with DOS regimen for 3 courses of treatment before surgery, and within 3-6 weeks after the completion of the third administration, preoperative imaging examination is used to evaluate the efficacy of new adjuvant treatment and the possibility of radical D2 resection, The patient underwent radical surgical treatment for gastric cancer and observed pCR | Drug | Adebrelimab combined with DOS |
Primary outcome
Pathological complete response rate（pCR）
Time frame: 7 days after surgery
Pathological complete response rate according to Becker standard
7 secondary outcomes
Major pathologic response (MPR)
Time frame: 7 days after surgery
Disease-free survival（DFS）
Time frame: Long term follow-up will continue until the death of the subject or the end of the study, at least three years
R0 resection rate
Time frame: postoperative 6 hours
Overall Survival（OS）
Time frame: Long term follow-up will continue until the death of the subject or the end of the study, at least three years
Objective response rate（ORR）
Time frame: 7 days before surgery
Event-free survival（EFS）
Time frame: Preoperative progression, postoperative recurrence, and death from any cause
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Long term follow-up will continue until the death of the subject or the end of the study, at least three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab combined with DOS in people with Gastric Cancer, run by Tang-Du 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 10 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 26 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nan Wang, Dr (15719286297, wangnandoc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate（pCR） (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2024.