GC/GEJCPhase 2NCT07770113
A Random, Non-controlled, Open Clinical Study of Apatinib Mesylate Combined With Albumin-bound Paclitaxel ± Adebrelimab in Treating Advanced Second-line Gastric Cancer
A Phase 2 study testing Adebrelimab, Apatinib and Albumin-bound paclitaxel in people with GC/GEJC, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
This study is a prospective, randomized, non-controlled, open-label clinical trial aimed at evaluating the efficacy and safety of adebrelimab combined with apatinib mesylate and albumin-bound paclitaxel, as well as apatinib mesylate combined with albumin-bound paclitaxel, in treating advanced second-line gastric… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- GC/GEJC
- What is being tested?
- Adebrelimab, Apatinib and Albumin-bound paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 30 Nov 2027
- 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
- Fully understand this study and voluntarily sign the informed consent form, with good compliance and cooperation during follow-up;
- Age ≥18 years and ≤80 years;
- ECOG score 0-1;
- Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced and unresectable, with local recurrence or distant metastasis;
- Her2 negative;
- Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma that has failed first-line systemic therapy: (1) Patients with postoperative recurrence or metastasis who progress during concurrent chemoradiotherapy also qualify; (2) For neoadjuvant/adjuvant therapy, if the patient progresses during treatment or within 6 months after treatment, it is also considered first-line systemic therapy failure; (3) If first-line therapy included immunotherapy, the PFS of a regimen containing immune checkpoint inhibitors must be at least 5 months;
Show all 17Show fewer
- Patient has at least one measurable lesion (according to RECIST 1.1 criteria);
- Major organ function is normal, i.e., meeting the following criteria:(1) Blood routine test standards must meet the following (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic stimulating factors for correction):
- Hemoglobin (Hb) ≥ 90 g/L; B. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; C. Platelet count (PLT) ≥ 80 × 10^9/L;
- Biochemical test standards must meet the following: A. Total bilirubin (TBIL) < 1.5 times the upper limit of normal (ULN); B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 ULN, and < 5 ULN for liver metastasis patients; C. Serum creatinine (Cr) ≤ 1.5 ULN or estimated creatinine clearance > 60 ml/min (Cockcroft-Gault formula); D. Urinalysis shows protein (UPRO) < 2 or 24-hour urine protein < 1 g;
- Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);
- Coagulation function: international normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time ≤1.5 × ULN;
- Lung function: forced expiratory volume in 1 second (FEV1) ≥1.2 L, FEV1% ≥50%, carbon monoxide diffusing capacity (DLCO) ≥50%;
- Echocardiography: left ventricular ejection fraction (LVEF) ≥50%;
- Electrocardiogram: QT interval corrected by Fridericia method (QTcF) <470 ms for females, <450 ms for males;
- Others: lipase ≤1.5 × ULN (patients with lipase >1.5 × ULN can be included if there is no clinical or imaging evidence of pancreatitis); amylase ≤1.5 × ULN (patients with amylase >1.5 × ULN can be included if there is no clinical or imaging evidence of pancreatitis); alkaline phosphatase (ALP) ≤2.5 ULN.
- Women of childbearing potential must agree to use effective contraception during the study and for 6 months after the study; must have a negative serum or urine pregnancy test within 7 days before enrollment, and must not be breastfeeding; men must agree to use contraception during the study and for 6 months after the study.
Who cannot join
- Those allergic to therapeutic drugs or those who have received first-line investigational drug treatment;
- Patients who have received first-line VEGFR inhibitor therapy, such as sorafenib, sunitinib, apatinib, etc.; Patients who have received first-line paclitaxel drugs.
- (1) Have received any investigational drug within 4 weeks prior to first use; (2) Subjects who require systemic corticosteroids (> 10 mg prednisone equivalent daily) or other immunosuppressants within 2 weeks prior to first use of the study drug, excluding cases of corticosteroid use targeting local esophageal inflammation and preventing allergies, nausea, and vomiting. (3) Other special circumstances require communication with the sponsor. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal corticosteroid replacement doses > 10 mg/day of prednisone are permitted; (4) Those who have received anti-tumor vaccines or received live vaccines within 4 weeks prior to the first administration of the study drug;
- Having any active autoimmune disease or a history of autoimmune diseases (such as interstitial lung).
- inflammation, uveitis, enteritis, hepatitis, pituititis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Excluding vitiligo or patients with recovered childhood asthma/allergies who do not require any intervention in adulthood; Patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes patients on stable doses of insulin may be included;
- History of immunodeficiency, including positive HIV testing, or other acquired or pre-acquired conditions Congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation;
Show all 11Show fewer
- Uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II or above Heart failure (2) Unstable angina pectoris (3) Myocardial infarction within 1 year (4) Subjects with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
- Severe infection within 4 weeks prior to first use of the study drug (CTC AE> level 2), Such as severe pneumonia, bacteremia, or complications such as infections requiring hospitalization; Baseline chest imaging indicates active lung inflammation, symptoms and signs of infection within 2 weeks prior to first use of the study drug, requiring oral or intravenous antibiotic treatment, except for prophylactic antibiotic use; History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute lung diseases; Patients with active pulmonary tuberculosis infection found through medical history or CT scan, or those with a history of active pulmonary tuberculosis infection within the past year prior to enrollment, or those with a history of active tuberculosis infection more than 1 year ago without formal treatment; Subjects with active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive, HCV-RNA above the detection lower limit of the assay);
- Before using the study drug for the first time, diagnosed with any other malignant tumor, except for those with low risk of metastasis and death (5-year survival rate >90%), such as fully treated basal cell or squamous cell skin cancer or cervical carcinoma in situ;
- Pregnant or breastfeeding women; subjects of reproductive potential who are unwilling or unable to use effective contraception;
- Patients deemed unsuitable for enrollment according to the investigator's judgment.
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
The First Affiliated Hospital of Henan University of Science and Technology
Zhengzhou, Henan, 450000
Yongxu Jia Chief Physician, +86 15237128281, jiayongxu111@126.com
About this study
This study is a prospective, randomized, non-controlled, open-label clinical trial aimed at evaluating the efficacy and safety of adebrelimab combined with apatinib mesylate and albumin-bound paclitaxel, as well as apatinib mesylate combined with albumin-bound paclitaxel, in treating advanced second-line gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
The study's primary endpoint is median progression-free survival (mPFS), and it plans to enroll 50 patients with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who failed first-line systemic therapy.
Read more
This is a randomized, non-controlled, open-label trial. Eligible participants will be randomly assigned in a 1:1 ratio to receive either adebrelimab combined with apatinib mesylate and albumin-bound paclitaxel (Cohort 1) or apatinib mesylate combined with albumin-bound paclitaxel (Cohort 2).
The screening phase is 28 days. After completing screening tests and assessments, eligible participants will be randomly assigned to the following treatments:
Cohort 1:
- Adebrelimab: 1200 mg, IV infusion, once every 21 days, until PD or intolerance, maximum use 2 years;
- Apatinib mesylate: 250 mg, orally, once daily, days 1-21; until PD or intolerance, maximum use 2 years;
- Albumin-bound paclitaxel: 200-260 mg/m², IV infusion, day 1, once every 21 days, for 4-6 cycles.
Cohort 2:
- Apatinib mesylate: 250 mg, orally, once daily, days 1-21; until PD or intolerance, maximum use 2 years;
- Albumin-bound paclitaxel: 200-260 mg/m², IV infusion, day 1, once every 21 days, for 4-6 cycles.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Adebrelimab：1200mg, IV infusion, given once every 21 days, until PD or intolerance, for up to 2 years;
ApatinibDrug
Apatinib：250mg, taken orally, once a day, days 1-21; continue until PD or intolerance, up to a maximum of 2 years;
Albumin-bound paclitaxelDrug
Albumin-bound paclitaxel：200-260 mg/m², intravenous infusion, on day 1, given once every 21 days, for 4-6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab+Apatinib+Albumin paclitaxel | Experimental | Not described Receives: Drug: Adebrelimab; Drug: Apatinib; Drug: Albumin-bound paclitaxel |
| Apatinib+Albumin paclitaxel | Experimental | Not described Receives: Drug: Apatinib; Drug: Albumin-bound paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median progression-free survival
Measured: The time from the first day of medication to disease progression or death, up to 24 months
Secondary outcomes (4)
Median overall survival
Measured: The time from the first day of taking the medication to death from any cause, up to 24 months.
Objective response rate
Measured: Every two cycles，every cycle consists of 21 days.
Duration of Response
Measured: The time from the tumor's first assessment as CR or PR to the first assessment as PD (Progressive Disease) or death from any cause, up to 24 months.
Adverse event rate
Measured: At the end of each cycle, every cycle consists of 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start30 Jun 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GC/GEJCStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongxu Jia, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770113
- Sponsor's protocol ID
- ADE-HN-GC-01
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 18 Aug 2026
- Results posted
- 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Random, Non-controlled, Open Clinical Study of Apatinib Mesylate Combined With Albumin-bound Paclitaxel ± Adebrelimab in Treating Advanced Second-line Gastric Cancer
- ClinicalTrials.gov ID
- NCT07770113
- Acronym / sponsor ID
- ADE-HN-GC-01
- Conditions
- GC/GEJC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 18 Aug 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 study is a prospective, randomized, non-controlled, open-label clinical trial aimed at evaluating the efficacy and safety of adebrelimab combined with apatinib mesylate and albumin-bound paclitaxel, as well as apatinib mesylate combined with albumin-bound paclitaxel, in treating advanced second-line gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
The study's primary endpoint is median progression-free survival (mPFS), and it plans to enroll 50 patients with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who failed first-line systemic therapy.
This is a randomized, non-controlled, open-label trial. Eligible participants will be randomly assigned in a 1:1 ratio to receive either adebrelimab combined with apatinib mesylate and albumin-bound paclitaxel (Cohort 1) or apatinib mesylate combined with albumin-bound paclitaxel (Cohort 2).
The screening phase is 28 days. After completing screening tests and assessments, eligible participants will be randomly assigned to the following treatments:
Cohort 1:
- Adebrelimab: 1200 mg, IV infusion, once every 21 days, until PD or intolerance, maximum use 2 years;
- Apatinib mesylate: 250 mg, orally, once daily, days 1-21; until PD or intolerance, maximum use 2 years;
- Albumin-bound paclitaxel: 200-260 mg/m², IV infusion, day 1, once every 21 days, for 4-6 cycles.
Cohort 2:
- Apatinib mesylate: 250 mg, orally, once daily, days 1-21; until PD or intolerance, maximum use 2 years;
- Albumin-bound paclitaxel: 200-260 mg/m², IV infusion, day 1, once every 21 days, for 4-6 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab+Apatinib+Albumin paclitaxel | Experimental | Drug: Adebrelimab, Drug: Apatinib, Drug: Albumin-bound paclitaxel |
| Apatinib+Albumin paclitaxel | Experimental | Drug: Apatinib, Drug: Albumin-bound paclitaxel |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Fully understand this study and voluntarily sign the informed consent form, with good compliance and cooperation during follow-up;
- Age ≥18 years and ≤80 years;
- ECOG score 0-1;
- Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced and unresectable, with local recurrence or distant metastasis;
- Her2 negative;
Key exclusion criteria (11 listed)
- Those allergic to therapeutic drugs or those who have received first-line investigational drug treatment;
- Patients who have received first-line VEGFR inhibitor therapy, such as sorafenib, sunitinib, apatinib, etc.; Patients who have received first-line paclitaxel drugs.
- (1) Have received any investigational drug within 4 weeks prior to first use; (2) Subjects who require systemic corticosteroids (> 10 mg prednisone equivalent daily) or other immunosuppressants within 2 weeks prior to first use of the study drug, excluding cases of corticosteroid use targeting local esophageal inflammation and preventing allergies, nausea, and vomiting. (3) Other special circumstances require communication with the sponsor. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal corticosteroid replacement doses > 10 mg/day of prednisone are permitted; (4) Those who have received anti-tumor vaccines or received live vaccines within 4 weeks prior to the first administration of the study drug;
- Having any active autoimmune disease or a history of autoimmune diseases (such as interstitial lung).
- inflammation, uveitis, enteritis, hepatitis, pituititis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Excluding vitiligo or patients with recovered childhood asthma/allergies who do not require any intervention in adulthood; Patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes patients on stable doses of insulin may be included;
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 |
|---|---|---|
| AdebrelimabAdebrelimab：1200mg, IV infusion, given once every 21 days, until PD or intolerance, for up to 2 years; | Drug | Adebrelimab+Apatinib+Albumin paclitaxel |
| ApatinibApatinib：250mg, taken orally, once a day, days 1-21; continue until PD or intolerance, up to a maximum of 2 years; | Drug | Adebrelimab+Apatinib+Albumin paclitaxel, Apatinib+Albumin paclitaxel |
| Albumin-bound paclitaxelAlbumin-bound paclitaxel：200-260 mg/m², intravenous infusion, on day 1, given once every 21 days, for 4-6 cycles. | Drug | Adebrelimab+Apatinib+Albumin paclitaxel, Apatinib+Albumin paclitaxel |
Primary outcome
Median progression-free survival
Time frame: The time from the first day of medication to disease progression or death, up to 24 months
4 secondary outcomes
Median overall survival
Time frame: The time from the first day of taking the medication to death from any cause, up to 24 months.
Objective response rate
Time frame: Every two cycles，every cycle consists of 21 days.
Duration of Response
Time frame: The time from the tumor's first assessment as CR or PR to the first assessment as PD (Progressive Disease) or death from any cause, up to 24 months.
Adverse event rate
Time frame: At the end of each cycle, every cycle consists of 21 days.
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 18 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for GC/GEJC
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
RecruitingPhase 3
A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Not yet recruitingPhase 2
Retlirafusp Alfa Combined With Zeprumetostat, Apatinib, and Chemotherapy as First-Line Treatment for Metastatic GC/GEJC
Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 1/2
A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors
Advanced Solid Tumor
Not yet recruitingPhase 2
Trastuzumab Combined With Retlirafusp Alfa in Treating HER2（Human Epidermal Growth Factor Receptor 2） 2+/3+ Gastric/Gastroesophageal Junction Adenocarcinoma After First-line Systemic Therapy Failure
GC, GEJC
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 Albumin-bound paclitaxel in people with GC/GEJC, run by The First Affiliated Hospital of Zhengzhou University 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 17 inclusion and 11 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 18 Aug 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 Yongxu Jia Chief Physician (15237128281, jiayongxu111@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median progression-free survival (time frame: The time from the first day of medication to disease progression or death, up to 24 months). 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 18 Aug 2026.