ClinicalTrials.gg
RecruitingNCT07770113Updated Aug 18, 2026

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 interventional study of Adebrelimab and Apatinib in GC/GEJC, sponsored by The First Affiliated Hospital of Zhengzhou University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by The First Affiliated Hospital of Zhengzhou University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jun 2025, registered Jun 2026).
  • Started Jun 2025; still recruiting 1 year 4 months later.

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Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • GC/GEJC
03

In context

Lead sponsor

The First Affiliated Hospital of Zhengzhou University is the lead sponsor of 127 studies on the registry; 74 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Fully understand this study and voluntarily sign the form, with good compliance and cooperation during follow-up;
  • Age ≥18 years and ≤80 years;
  • score 0-1;
  • or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced and unresectable, with local recurrence or distant ;
  • Her2 negative;
  • Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma that has failed systemic therapy: (1) Patients with postoperative recurrence or metastasis who progress during concurrent chemoradiotherapy also qualify; (2) For /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 must be at least 5 months;
  • Patient has at least one (according to 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):

A. (Hb) ≥ 90 g/L; B. (ANC) ≥ 1.5 × 10\^9/L; C. count (PLT) ≥ 80 × 10\^9/L;

(2) Biochemical test standards must meet the following: A. Total (TBIL) \< 1.5 times the (ULN); B. (ALT) and aspartate aminotransferase (AST) \< 2.5 ULN, and \< 5 ULN for liver metastasis patients; C. Serum creatinine (Cr) ≤ 1.5 ULN or estimated > 60 ml/min (Cockcroft-Gault formula); D. Urinalysis shows protein (UPRO) \< 2 or 24-hour urine protein \< 1 g;

(3) Doppler ultrasound assessment: (LVEF) ≥ lower limit of normal (50%);

(4) Coagulation function: (INR) ≤1.5 × ULN and activated partial thromboplastin time ≤1.5 × ULN;

(5) Lung function: (FEV1) ≥1.2 L, FEV1% ≥50%, carbon monoxide diffusing capacity (DLCO) ≥50%;

(6) Echocardiography: left ventricular ejection fraction (LVEF) ≥50%;

(7) : corrected by Fridericia method (QTcF) \<470 ms for females, \<450 ms for males;

(8) 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 must agree to use effective 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.

Exclusion criteria

Exclusion Criteria:

  • Those allergic to therapeutic drugs or those who have received 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 (> 10 mg prednisone equivalent daily) or other 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 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 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 testing, or other acquired or pre-acquired conditions Congenital immunodeficiency diseases, or history of organ transplantation and bone marrow transplantation;
  • Uncontrolled cardiac clinical symptoms or diseases, such as (1) II or above Heart failure (2) Unstable angina pectoris (3) Myocardial infarction within 1 year (4) Subjects with 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 (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), (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 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 who are unwilling or unable to use effective ;
  • Patients deemed unsuitable for enrollment according to the investigator's judgment.
Terms in these criteria, in plain language(35)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumor. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumor sample. Some scores count stained tumor cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumor measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumor visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumors on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumor 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Adebrelimab+Apatinib+Albumin paclitaxel

    Drug: Adebrelimab · Drug: Apatinib · Drug: Albumin-bound paclitaxel

  • Experimental
    Apatinib+Albumin paclitaxel

    Drug: Apatinib · Drug: Albumin-bound paclitaxel

Interventions

  • Adebrelimab:1200mg, IV infusion, given once every 21 days, until PD or intolerance, for up to 2 years;

  • Apatinib:250mg, taken orally, once a day, days 1-21; continue until PD or intolerance, up to a maximum of 2 years;

  • Albumin-bound paclitaxel:200-260 mg/m², intravenous infusion, on day 1, given once every 21 days, for 4-6 cycles.

06

What researchers measure

Primary outcomes

  1. Median progression-free survival

    Time frame: The time from the first day of medication to disease progression or death, up to 24 months

Secondary outcomes

  1. Median overall survival

    Time frame: The time from the first day of taking the medication to death from any cause, up to 24 months.

  2. Objective response rate

    Time frame: Every two cycles,every cycle consists of 21 days.

  3. 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.

  4. Adverse event rate

    Time frame: At the end of each cycle, every cycle consists of 21 days.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2025 (actual). Primary completion is estimated for Nov 2026, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2026
First posted
Aug 18, 2026
StartActual
Jun 30, 2025
Primary completionEst.
Nov 30, 2026
CompletionEst.
Nov 30, 2027
Last update
Aug 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07770113
Responsible party
Yongxu Jia (Chief Physician, The First Affiliated Hospital of Zhengzhou University) — Principal investigator
First posted
Aug 18, 2026
Start date
Jun 30, 2025
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2027 (estimated)
Last update
Aug 18, 2026

Study contacts

Yongxu Jia Chief Physician
Contact
jiayongxu111@126.com
15237128281

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Apatinib · Albumin-Bound Paclitaxel

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