AdebrelimabPhase 2NCT07353684
Adebrelimab Plus Apatinib Combined With SOX Regimen as Conversion Therapy for Gastric Cancer
A Phase 2 study testing Adebrelimab, Apatinib and SOX Chemotherapy in people with Adebrelimab and Adenocarcinoma of GE Junction, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This is a prospective, single-center, single-arm, open phase II clinical study. Forty-nine participants with pathologically or cytologically confirmed gastric cancer or gastroesophageal junction cancer are scheduled to be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adebrelimab, Adenocarcinoma of GE Junction, Adenocarcinoma of Stomach
- What is being tested?
- Adebrelimab, Apatinib and SOX Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2025to 31 May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years at the time of enrollment, with an estimated life expectancy of ≥ 3 months.
- Histologically or cytologically confirmed gastric cancer or gastroesophageal junction cancer, predominantly adenocarcinoma.
- Unresectable locally advanced gastric or gastroesophageal junction adenocarcinoma (Stage III or IV), as determined by the investigator based on CT, MRI, and/or PET-CT.
- Disease with conversion (translational) therapeutic potential, as assessed by the investigator.
- No prior anti-tumor treatment, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other systemic anticancer therapies.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
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- Adequate hematologic function within 14 days prior to enrollment:
- White blood cell count ≥ 3.5 × 10⁹/L.
- Absolute neutrophil count ≥ 1.5 × 10⁹/L.
- Hemoglobin ≥ 90 g/L (9.0 g/dL).
- Platelet count ≥ 100 × 10⁹/L.
- Adequate hepatic function within 14 days prior to enrollment:Total bilirubin ≤ 1.5 × upper limit of normal (ULN);ALT and AST ≤ 2.5 × ULN in patients without liver metastases;ALT and AST ≤ 5 × ULN in patients with liver metastases;Adequate renal function:Serum creatinine ≤ 1.5 × ULN;Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and agree to use effective contraception during the study and for at least 12 weeks after the last dose.
- Male participants must be surgically sterile or agree to use effective contraception during the study and for at least 12 weeks after the last dose
- Ability to understand and willingness to sign a written informed consent form
- Expected to comply with study procedures and follow-up requirements
Who cannot join
- HER2-positive gastric or gastroesophageal junction adenocarcinoma.
- Conditions that may significantly affect oral drug absorption, including inability to swallow, persistent nausea or vomiting, chronic diarrhea, or intestinal obstruction.
- Known hypersensitivity or allergy to adebrelimab, apatinib, oxaliplatin, S-1 (tegafur/gimeracil/oteracil), or any of their excipients.
- History of severe allergic reactions to monoclonal antibodies.
- Active autoimmune disease or autoimmune disorders requiring systemic treatment.
- Congenital or acquired immunodeficiency.
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- Use of systemic immunosuppressive therapy within 14 days prior to the first dose of study treatment.
- Administration of live attenuated vaccines within 4 weeks prior to the first dose or planned during the study period.
- Severe infection within 4 weeks prior to initiation of study treatment.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Evidence of interstitial lung disease, including pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severely impaired pulmonary function.
- Uncontrolled hypertension despite at least 3 months of antihypertensive treatment.
- Uncontrolled clinically significant cardiovascular disease.
- High risk of severe bleeding, as judged by the investigator.
- Peripheral neuropathy of Grade > 2 according to CTCAE.
- Participation in another interventional clinical trial within 4 weeks prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for study participation.
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
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Wei Deng, MD, +8613426136152 ext. 010-63138712, dengweiwei@126.com
About this study
Official title: Phase II Clinical Study of Adebrelimab Plus Apatinib and SOX Regimen for Conversion Therapy of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
This is a prospective, single-center, single-arm, open phase II clinical study. Forty-nine participants with pathologically or cytologically confirmed gastric cancer or gastroesophageal junction cancer are scheduled to be enrolled in this study. All participants will be treated with 2 to 8 cycles of adebrelimab, apatinib, oxaliplatin, and tigio before surgery. Participants will evaluate the treatment effect after every 2 cycles of medication. By the investigator assessment as an operable subject, apatinib was discontinued for one cycle. The adjuvant treatment will be determined by the investigators based on the participants' postoperative pathology results. Participants requiring adjuvant therapy, with a postoperative interval of at least 4 weeks, but not more than 10 weeks. When the resection standard isn't met for 8 cycles of treatment, the treatment is switched to a maintenance phase, which the subject treatment regimen is determined by the investigator. During the treatment period, participants will receive the study drugs on Day 1 of each 21-day cycle until evidence of disease progression or unacceptable toxicity.
Read the detailed description
Study Design: This is a prospective, single-center, single-arm, open-label Phase II clinical study. The study aims to evaluate the efficacy and safety of Adebrelimab combined with Apatinib and SOX regimen as conversion therapy for patients with advanced, unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study plans to enroll approximately 49 participants who are assessed by investigators as having conversion therapy potential (defined as single organ metastasis, retroperitoneal lymph node metastasis, supraclavicular lymph node metastasis, limited peritoneal metastasis, or invasion of surrounding organs).
Treatment Protocol: Eligible participants will receive a four-drug combination therapy consisting of Adebrelimab, Apatinib Mesylate, Oxaliplatin, and S-1. The treatment is administered in 3-week cycles:
Adebrelimab: 1200 mg, intravenous infusion on Day 1.
Apatinib Mesylate: 250 mg, oral, once daily.
Oxaliplatin: 130 mg/m², intravenous infusion on Day 1.
S-1 (Tegafur, Gimeracil, and Oteracil Potassium): 40-60 mg (based on Body Surface Area), oral, twice daily on Days 1-14.
Study Procedures and Phases:
Conversion Treatment Phase: Patients will receive treatment for a minimum of 2 cycles and a maximum of 8 cycles. Resectability will be assessed by the investigator every 2 cycles using imaging evaluation.
Surgical Intervention:
If the tumor is assessed as resectable: Apatinib will be discontinued for one cycle prior to the planned surgery to ensure safety.
Surgery should be performed between 3 to 6 weeks (maximum 6 weeks) after the last dose of the study drug.
Post-operative Phase: The decision to administer adjuvant therapy will be made by the investigator based on post-operative pathological results. If adjuvant therapy is required, it will commence at least 4 weeks but no later than 10 weeks after surgery.
Maintenance Phase: If the tumor remains unresectable after 8 cycles of combination therapy, the patient will transition to a maintenance phase. The specific treatment regimen during the maintenance phase will be determined by the investigator based on the patient's condition.
Follow-up: Upon discontinuation of treatment, patients will undergo safety follow-ups every 30 days until 90 days after the last dose. Subsequently, patients will enter the survival follow-up period to monitor disease recurrence, metastasis, and overall survival. Follow-ups will occur every 3 months for the first 2 years and every 6 months for years 2 to 5.
- Being tested
- Adebrelimab, Apatinib, SOX Chemotherapy
- Keywords
- adebrelimab, Adenocarcinoma of GE junction, Adenocarcinoma of stomach, conversion therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
1200 mg, iv.gtt, single infusion, 21 days as a cycle, Day 1
ApatinibDrug
250mg, p.o, qd, 21 days as a cycle
SOX ChemotherapyDrug
Oxaliplatin: 130mg/m2, iv.gtt, single infusion, 21 days as a cycle, Day 1. Tigio: 40mg (body surface area(BSA)<1.25m2), 50mg (BSA≥1.25m2, and BAS<1.5m2), 60mg (BSA ≥1.5m2), p.o, bid, 21 days as a cycle, Day 1-14.
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab + Apatinib + SOX | Experimental | Participants receive Adebrelimab, Apatinib, Oxaliplatin, and S-1 as conversion therapy. Treatment is administered in 3-week cycles for 2-8 cycles, followed by surgical assessment. Receives: Drug: Adebrelimab; Drug: Apatinib; Drug: SOX Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Proportion of participants who achieve R0 resection, defined as microscopically margin-negative resection confirmed by postoperative pathological examination.
Measured: At the time of definitive surgery following completion of neoadjuvant treatment (within 6 months from enrollment)
Adverse Events (AE)
Incidence, nature, and severity of treatment-emergent adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Measured: From treatment initiation to 30 days after the last dose of study treatment (up to approximately 6 months).
Secondary outcomes (3)
Objective response rate (ORR)
ORR is defined as the percentage of participants who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: up to 1year
Overall survival (OS)
Time from day of study to death due to any cause.
Measured: Up to 3 years
Disease Free Survival (PFS)
Time from enrollment to disease progression or death from any cause, whichever occurs first.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start11 May 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdebrelimabStudies 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
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deng Wei, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353684
- Sponsor's protocol ID
- BFHHS20250003
- Other IDs
- BFHHS20250003
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Adebrelimab Plus Apatinib and SOX Regimen for Conversion Therapy of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07353684
- Acronym / sponsor ID
- BFHHS20250003
- Keywords
- adebrelimab, Adenocarcinoma of GE junction, Adenocarcinoma of stomach, conversion therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 11 May 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 20 Jan 2026 (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.
This is a prospective, single-center, single-arm, open phase II clinical study. Forty-nine participants with pathologically or cytologically confirmed gastric cancer or gastroesophageal junction cancer are scheduled to be enrolled in this study. All participants will be treated with 2 to 8 cycles of adebrelimab, apatinib, oxaliplatin, and tigio before surgery. Participants will evaluate the treatment effect after every 2 cycles of medication. By the investigator assessment as an operable subject, apatinib was discontinued for one cycle. The adjuvant treatment will be determined by the investigators based on the participants' postoperative pathology results. Participants requiring adjuvant therapy, with a postoperative interval of at least 4 weeks, but not more than 10 weeks. When the resection standard isn't met for 8 cycles of treatment, the treatment is switched to a maintenance phase, which the subject treatment regimen is determined by the investigator. During the treatment period, participants will receive the study drugs on Day 1 of each 21-day cycle until evidence of disease progression or unacceptable toxicity.
Detailed description
Study Design: This is a prospective, single-center, single-arm, open-label Phase II clinical study. The study aims to evaluate the efficacy and safety of Adebrelimab combined with Apatinib and SOX regimen as conversion therapy for patients with advanced, unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study plans to enroll approximately 49 participants who are assessed by investigators as having conversion therapy potential (defined as single organ metastasis, retroperitoneal lymph node metastasis, supraclavicular lymph node metastasis, limited peritoneal metastasis, or invasion of surrounding organs).
Treatment Protocol: Eligible participants will receive a four-drug combination therapy consisting of Adebrelimab, Apatinib Mesylate, Oxaliplatin, and S-1. The treatment is administered in 3-week cycles:
Adebrelimab: 1200 mg, intravenous infusion on Day 1.
Apatinib Mesylate: 250 mg, oral, once daily.
Oxaliplatin: 130 mg/m², intravenous infusion on Day 1.
S-1 (Tegafur, Gimeracil, and Oteracil Potassium): 40-60 mg (based on Body Surface Area), oral, twice daily on Days 1-14.
Study Procedures and Phases:
Conversion Treatment Phase: Patients will receive treatment for a minimum of 2 cycles and a maximum of 8 cycles. Resectability will be assessed by the investigator every 2 cycles using imaging evaluation.
Surgical Intervention:
If the tumor is assessed as resectable: Apatinib will be discontinued for one cycle prior to the planned surgery to ensure safety.
Surgery should be performed between 3 to 6 weeks (maximum 6 weeks) after the last dose of the study drug.
Post-operative Phase: The decision to administer adjuvant therapy will be made by the investigator based on post-operative pathological results. If adjuvant therapy is required, it will commence at least 4 weeks but no later than 10 weeks after surgery.
Maintenance Phase: If the tumor remains unresectable after 8 cycles of combination therapy, the patient will transition to a maintenance phase. The specific treatment regimen during the maintenance phase will be determined by the investigator based on the patient's condition.
Follow-up: Upon discontinuation of treatment, patients will undergo safety follow-ups every 30 days until 90 days after the last dose. Subsequently, patients will enter the survival follow-up period to monitor disease recurrence, metastasis, and overall survival. Follow-ups will occur every 3 months for the first 2 years and every 6 months for years 2 to 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab + Apatinib + SOX | Experimental | Drug: Adebrelimab, Drug: Apatinib, Drug: SOX ChemotherapyParticipants receive Adebrelimab, Apatinib, Oxaliplatin, and S-1 as conversion therapy. Treatment is administered in 3-week cycles for 2-8 cycles, followed by surgical assessment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18-75 years at the time of enrollment, with an estimated life expectancy of ≥ 3 months.
- Histologically or cytologically confirmed gastric cancer or gastroesophageal junction cancer, predominantly adenocarcinoma.
- Unresectable locally advanced gastric or gastroesophageal junction adenocarcinoma (Stage III or IV), as determined by the investigator based on CT, MRI, and/or PET-CT.
- Disease with conversion (translational) therapeutic potential, as assessed by the investigator.
- No prior anti-tumor treatment, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other systemic anticancer therapies.
Key exclusion criteria (17 listed)
- HER2-positive gastric or gastroesophageal junction adenocarcinoma.
- Conditions that may significantly affect oral drug absorption, including inability to swallow, persistent nausea or vomiting, chronic diarrhea, or intestinal obstruction.
- Known hypersensitivity or allergy to adebrelimab, apatinib, oxaliplatin, S-1 (tegafur/gimeracil/oteracil), or any of their excipients.
- History of severe allergic reactions to monoclonal antibodies.
- Active autoimmune disease or autoimmune disorders requiring systemic 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 |
|---|---|---|
| Adebrelimab1200 mg, iv.gtt, single infusion, 21 days as a cycle, Day 1 | Drug | Adebrelimab + Apatinib + SOX |
| Apatinib250mg, p.o, qd, 21 days as a cycle | Drug | Adebrelimab + Apatinib + SOX |
| SOX ChemotherapyOxaliplatin: 130mg/m2, iv.gtt, single infusion, 21 days as a cycle, Day 1. Tigio: 40mg (body surface area(BSA)<1.25m2), 50mg (BSA≥1.25m2, and BAS<1.5m2), 60mg (BSA ≥1.5m2), p.o, bid, 21 days as a cycle, Day 1-14. | Drug | Adebrelimab + Apatinib + SOX |
Primary outcome
R0 resection rate
Time frame: At the time of definitive surgery following completion of neoadjuvant treatment (within 6 months from enrollment)
Proportion of participants who achieve R0 resection, defined as microscopically margin-negative resection confirmed by postoperative pathological examination.
Adverse Events (AE)
Time frame: From treatment initiation to 30 days after the last dose of study treatment (up to approximately 6 months).
Incidence, nature, and severity of treatment-emergent adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
3 secondary outcomes
Objective response rate (ORR)
Time frame: up to 1year
Overall survival (OS)
Time frame: Up to 3 years
Disease Free Survival (PFS)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Adebrelimab
Not yet recruitingPhase 3
A Study of Perioperative Adebrelimab Plus Chemotherapy Versus Adjuvant Therapy in Patients With Resectable NSCLC
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RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
Not yet recruitingPhase 3
A Study of SHR-A1811 Combined With Adebrelimab for the First-line HER2-overexpressing Non-squamous Non-small Cell Lung Cancer
Non Small Cell Lung Cancer
Not yet recruitingPhase 1
A Phase I Study of HS-20093 in Combination With ZG006 With or Without Adebrelimab in Patients With ES-SCLC
Extensive Stage Small Cell Lung Cancer (ES-SCLC)
RecruitingPhase 2
A Phase II Study of HS-20093 Injection Combined With Adebrelimab Versus HS-20093 Injection in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
Non-Small Cell Lung Cancer
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.
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, Apatinib and SOX Chemotherapy in people with Adebrelimab and Adenocarcinoma of GE Junction, run by Beijing Friendship 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 15 inclusion and 17 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 Apr 2026. 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 Wei Deng, MD (+8613426136152 ext. 010-63138712, dengweiwei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: At the time of definitive surgery following completion of neoadjuvant treatment (within 6 months from enrollment)). The study lists 2 primary outcomes in all. 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 22 Apr 2026.