Gastric CancerG/GEJNCT07389876
Albumin-bound Paclitaxel-based Second-line Treatment Regimens for Locally Advanced or Metastatic G/GEJ Adenocarcinoma
An observational study of Gastric Cancer and Second-line Treatment, run by Fudan University at 1 site in China.
Trial summary
This study is an open-label, multi-cohort real-world research that explores the efficacy and safety of different second-line treatment regimens for gastric/gastroesophageal junction adenocarcinoma that has failed first-line fluoropyrimidine, platinum-based chemotherapy combined with immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Second-line Treatment
- What is being tested?
- Albumin-bound Paclitaxel, Immune Checkpoint Inhibitor and Anti-angiogenic drug
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Sep 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: 250
Who may be able to join
- Fully understand this study and voluntarily sign the informed consent form;
- Between 18 and 80 years old (inclusive), male or female;
- Patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or histology;
- ECOG performance status 0-2;
- Known HER2 negative;
- Expected survival ≥ 3 months;
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- Patients who have progressed on first-line systemic treatment with fluoropyrimidine-platinum combination and PD-1/PD-L1 monoclonal antibody, or those who have progressed during maintenance treatment; patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have progressed within 6 months after the end of perioperative chemotherapy or adjuvant chemotherapy (counting from the end of the combined regimen);
- Have not received taxane-based therapy previously;
- Have at least one measurable lesion (meeting RECIST v1.1 criteria);
- The functions of important organs meet the following requirements (no blood components or cell growth factors are allowed to be used within 14 days before enrollment):
- Absolute neutrophil count ≥ 1.5×109/L, white blood cell count ≥ 3.0×109/L; Platelet count ≥ 90×109/L; Hemoglobin ≥ 8g/dL; Total bilirubin (TBIL) ≤ 1.5×ULN; ALT and AST ≤ 2.5×ULN; BUN and creatinine (Cr) ≤ 1.5×ULN (and creatinine clearance (CCr) ≥ 50mL/min); Left ventricular ejection fraction (LVEF) ≥ 50%; Fridericia-corrected QT interval (QTcF) < 470 milliseconds; INR ≤ 1.5×ULN, APTT ≤ 1.5×ULN; Thyroid function: TSH ≤ upper limit of normal (ULN). If abnormal, FT3 and FT4 levels should be examined. If FT3 and FT4 levels are normal, the patient can be enrolled; Premenopausal women and postmenopausal women for less than 1 year must have a negative serum or urine pregnancy test before treatment.
Who cannot join
- Patients with other malignancies within 5 years before enrollment, except for skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
- Patients who have received allogeneic bone marrow transplantation or organ transplantation in the past;
- Patients with severe cardiovascular diseases within 6 months before enrollment, including unstable angina or myocardial infarction;
- Patients allergic to the study drug or any of its auxiliary preparations;
- Patients with uncontrolled hypertension before enrollment, defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 90 mmHg;
- Patients with any disease or condition that affects drug absorption before enrollment, or patients who cannot take oral medication;
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- Patients with active ulcers in the stomach and duodenum, ulcerative colitis or other digestive tract diseases before enrollment, or unremoved tumors with active bleeding, or other conditions that the investigator deems may cause gastrointestinal bleeding or perforation;
- Patients with obvious bleeding tendency evidence or history within 3 months before enrollment (bleeding > 30 mL within 3 months, accompanied by hematemesis, melena, or hematochezia), hemoptysis (fresh blood > 5 mL within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months;
- Patients with significant clinical cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina or coronary artery bypass grafting within 6 months before enrollment; congestive heart failure with New York Heart Association (NYHA) classification > 2; drug-treated ventricular arrhythmias; left ventricular ejection fraction (LVEF) < 50%;
- Patients with active or uncontrolled severe infections (≥ CTCAE v5.0 grade 2 infections);
- Patients with known human immunodeficiency virus (HIV) infection. Patients with a history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must exclude active HBV infection, i.e., HBV DNA positive (> 1×104 copies/mL or > 2000 IU/mL); known hepatitis C virus (HCV) infection and HCV RNA positive (> 1×103 copies/mL)];
- Patients with any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; patients with childhood asthma that has completely resolved and does not require any intervention in adulthood can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included); replacement therapy is not considered systemic treatment, the following patients can be included: those with a history of autoimmune-related hypothyroidism and receiving thyroid hormone replacement therapy; type 1 diabetes that can be controlled with insulin treatment;
- Patients who have used immunosuppressants or systemic hormone therapy to achieve immunosuppression within 7 days before enrollment (dose > 10 mg/day of prednisone or other equivalent efficacy hormones);
- Patients with interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, or radiation pneumonitis;
- Pregnant (positive pregnancy test before medication) or lactating women; Any other disease, clinically significant metabolic abnormalities, physical examination abnormalities or laboratory test abnormalities, as judged by the investigator, there is reason to suspect that the patient has a disease or condition that is not suitable for the use of the study drug (such as having epilepsy and requiring treatment), or will affect the interpretation of the study results, or put the patient at high risk;
- Patients with urine routine indicating urine protein ≥ 2+ and 24-hour urine protein > 1.0g;
- Patients deemed unsuitable for inclusion in this study by the investigator.
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
Wanjing Feng
Shanghai, Shanghai Municipality, 200032
Wanjing Feng, +86 021-64175590, 1915659989@qq.com
About this study
Official title: A Multicenter, Real-world Study on Albumin-bound Paclitaxel-based Second-line Treatment Regimens for Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
This study is an open-label, multi-cohort real-world research that explores the efficacy and safety of different second-line treatment regimens for gastric/gastroesophageal junction adenocarcinoma that has failed first-line fluoropyrimidine, platinum-based chemotherapy combined with immunotherapy.
Read the detailed description
Group A (Albumin-bound Paclitaxel Monotherapy Group): Albumin-bound paclitaxel: 112.5 mg/m², intravenous infusion, on days 1 and 8, every 3 weeks.
Group B (Albumin-bound Paclitaxel with Anti-angiogenic Therapy Group): Fruquintinib 4 mg/day, once daily orally, on days 1 to 14, every 3 weeks or Ramucirumab 8 mg/kg on days 1 and 15, every 4 weeks; Albumin-bound paclitaxel: 112.5 mg/m², intravenous infusion, on days 1 and 8, every 3 weeks.
Group C (Albumin-bound Paclitaxel with Immune Checkpoint Inhibitor Group): Immune checkpoint inhibitor (refer to the drug instructions); Albumin-bound paclitaxel: 112.5 mg/m², intravenous infusion, on days 1 and 8, every 3 weeks.
Group D (Albumin-bound Paclitaxel with Immune Checkpoint Inhibitor and Anti-angiogenic Therapy Group): Fruquintinib 4 mg/day, once daily orally, on days 1 to 14, every 3 weeks or Ramucirumab 8 mg/kg on days 1 and 15, every 4 weeks; PD-1 200mg d1, Q3W; Albumin-bound paclitaxel: 112.5 mg/m2, i.v. infusion, on days 1 and 8, every 3 weeks.
Group E (albumin-bound paclitaxel and trastuzumab emtansine group): Trastuzumab emtansine group (initial dose 800 mg/m2, subsequent doses 600-800 mg/m2); Albumin-bound paclitaxel: 112.5 mg/m2, i.v. infusion, on days 1 and 8, every 3 weeks (only patients with Claudin18.2 positive and who did not receive trastuzumab emtansine in the first-line treatment were included).
Treatment continued until disease progression or intolerable toxicity.
- Conditions
- Gastric Cancer, Second-line Treatment
- Being tested
- Albumin-bound Paclitaxel, Immune Checkpoint Inhibitor, Anti-angiogenic drug, Trastuzumab emtansine
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin-bound PaclitaxelDrug
This is a prospective observational study. We observe efficacy and survival of different treatment regimen.
Immune Checkpoint InhibitorDrug
Immune Checkpoint Inhibitor
Anti-angiogenic drugDrug
Anti-angiogenic drug
Trastuzumab emtansineDrug
Trastuzumab Emtansine
| Study group | Role | What they receive |
|---|---|---|
| Group A (Albumin-bound Paclitaxel Monotherapy Group) | Albumin-bound paclitaxel: 112.5 mg/m2, ivgtt, d1, d8, Q3W Receives: Drug: Albumin-bound Paclitaxel | |
| Group B (Albumin-bound Paclitaxel and Anti-angiogenic Therapy Group) | Fruquintinib 4 mg/d, qd po, d1-14, Q3W or Ramucirumab 8 mg/kg d1, 15 Q4W; Albumin-bound paclitaxel: 112.5 mg/m2, ivgtt, d1, d8, Q3W Receives: Drug: Albumin-bound Paclitaxel; Drug: Anti-angiogenic drug | |
| Group C (Albumin-bound Paclitaxel and Immune Checkpoint Inhibitor Group) | Immune checkpoint inhibitor (refer to the drug instructions); Albumin-bound paclitaxel: 112.5 mg/m2, ivgtt, d1, d8, Q3W Receives: Drug: Albumin-bound Paclitaxel; Drug: Immune Checkpoint Inhibitor | |
| Group D (Albumin-bound Paclitaxel, Immune Checkpoint Inhibitor and Anti-angiogenic Therapy Group) | : Fruquintinib 4 mg/d, qd po, d1-14, Q3W or Ramucirumab 8 mg/kg d1, 15 Q4W; Immune checkpoint inhibitor (refer to the drug instructions); Albumin-bound paclitaxel: 112.5 mg/m2, ivgtt, d1, d8, Q3W Receives: Drug: Albumin-bound Paclitaxel; Drug: Immune Checkpoint Inhibitor; Drug: Anti-angiogenic drug | |
| Group E (Albumin-bound Paclitaxel and Trastuzumab Emtansine Group) | Trastuzumab emtansine (first dose 800 mg/m2, subsequent doses 600 mg/m2), ivgtt, Q3W; Albumin-bound paclitaxel: 112.5 mg/m2, ivgtt, d1, d8, Q3W Receives: Drug: Albumin-bound Paclitaxel; Drug: Trastuzumab emtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
The rate of complete response and partial response
Measured: the duration from the date of randomization to any documented tumor progression or death due to any cause, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (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 Fudan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodong Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389876
- Sponsor's protocol ID
- FDZL-NabPMGC
- Acronym
- G/GEJ
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We would like to share data if request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Real-world Study on Albumin-bound Paclitaxel-based Second-line Treatment Regimens for Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07389876
- Acronym / sponsor ID
- G/GEJ / FDZL-NabPMGC
- Conditions
- Gastric Cancer, Second-line Treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 5 Feb 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 an open-label, multi-cohort real-world research that explores the efficacy and safety of different second-line treatment regimens for gastric/gastroesophageal junction adenocarcinoma that has failed first-line fluoropyrimidine, platinum-based chemotherapy combined with immunotherapy.
Detailed description
Group A (Albumin-bound Paclitaxel Monotherapy Group): Albumin-bound paclitaxel: 112.5 mg/m², intravenous infusion, on days 1 and 8, every 3 weeks.
Group B (Albumin-bound Paclitaxel with Anti-angiogenic Therapy Group): Fruquintinib 4 mg/day, once daily orally, on days 1 to 14, every 3 weeks or Ramucirumab 8 mg/kg on days 1 and 15, every 4 weeks; Albumin-bound paclitaxel: 112.5 mg/m², intravenous infusion, on days 1 and 8, every 3 weeks.
Group C (Albumin-bound Paclitaxel with Immune Checkpoint Inhibitor Group): Immune checkpoint inhibitor (refer to the drug instructions); Albumin-bound paclitaxel: 112.5 mg/m², intravenous infusion, on days 1 and 8, every 3 weeks.
Group D (Albumin-bound Paclitaxel with Immune Checkpoint Inhibitor and Anti-angiogenic Therapy Group): Fruquintinib 4 mg/day, once daily orally, on days 1 to 14, every 3 weeks or Ramucirumab 8 mg/kg on days 1 and 15, every 4 weeks; PD-1 200mg d1, Q3W; Albumin-bound paclitaxel: 112.5 mg/m2, i.v. infusion, on days 1 and 8, every 3 weeks.
Group E (albumin-bound paclitaxel and trastuzumab emtansine group): Trastuzumab emtansine group (initial dose 800 mg/m2, subsequent doses 600-800 mg/m2); Albumin-bound paclitaxel: 112.5 mg/m2, i.v. infusion, on days 1 and 8, every 3 weeks (only patients with Claudin18.2 positive and who did not receive trastuzumab emtansine in the first-line treatment were included).
Treatment continued until disease progression or intolerable toxicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A (Albumin-bound Paclitaxel Monotherapy Group) | – | Drug: Albumin-bound PaclitaxelAlbumin-bound paclitaxel: 112.5 mg/m2, ivgtt, d1, d8, Q3W |
| Group B (Albumin-bound Paclitaxel and Anti-angiogenic Therapy Group) | – | Drug: Albumin-bound Paclitaxel, Drug: Anti-angiogenic drugFruquintinib 4 mg/d, qd po, d1-14, Q3W or Ramucirumab 8 mg/kg d1, 15 Q4W; Albumin-bound paclitaxel: 112.5 mg/m2, ivgtt, d1, d8, Q3W |
| Group C (Albumin-bound Paclitaxel and Immune Checkpoint Inhibitor Group) | – | Drug: Albumin-bound Paclitaxel, Drug: Immune Checkpoint InhibitorImmune checkpoint inhibitor (refer to the drug instructions); Albumin-bound paclitaxel: 112.5 mg/m2, ivgtt, d1, d8, Q3W |
| Group D (Albumin-bound Paclitaxel, Immune Checkpoint Inhibitor and Anti-angiogenic Therapy Group) | – | Drug: Albumin-bound Paclitaxel, Drug: Immune Checkpoint Inhibitor, Drug: Anti-angiogenic drug: Fruquintinib 4 mg/d, qd po, d1-14, Q3W or Ramucirumab 8 mg/kg d1, 15 Q4W; Immune checkpoint inhibitor (refer to the drug instructions); Albumin-bound paclitaxel: 112.5 mg/m2, ivgtt, d1, d8, Q3W |
| Group E (Albumin-bound Paclitaxel and Trastuzumab Emtansine Group) | – | Drug: Albumin-bound Paclitaxel, Drug: Trastuzumab emtansineTrastuzumab emtansine (first dose 800 mg/m2, subsequent doses 600 mg/m2), ivgtt, Q3W; Albumin-bound paclitaxel: 112.5 mg/m2, ivgtt, d1, d8, Q3W |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 250
Key inclusion criteria (11 listed)
- Fully understand this study and voluntarily sign the informed consent form;
- Between 18 and 80 years old (inclusive), male or female;
- Patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or histology;
- ECOG performance status 0-2;
- Known HER2 negative;
Key exclusion criteria (17 listed)
- Patients with other malignancies within 5 years before enrollment, except for skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
- Patients who have received allogeneic bone marrow transplantation or organ transplantation in the past;
- Patients with severe cardiovascular diseases within 6 months before enrollment, including unstable angina or myocardial infarction;
- Patients allergic to the study drug or any of its auxiliary preparations;
- Patients with uncontrolled hypertension before enrollment, defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 90 mmHg;
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 |
|---|---|---|
| Albumin-bound PaclitaxelThis is a prospective observational study. We observe efficacy and survival of different treatment regimen. | Drug | Group A (Albumin-bound Paclitaxel Monotherapy Group), Group B (Albumin-bound Paclitaxel and Anti-angiogenic Therapy Group), Group C (Albumin-bound Paclitaxel and Immune Checkpoint Inhibitor Group), Group D (Albumin-bound Paclitaxel, Immune Checkpoint Inhibitor and Anti-angiogenic Therapy Group), Group E (Albumin-bound Paclitaxel and Trastuzumab Emtansine Group) |
| Immune Checkpoint InhibitorImmune Checkpoint Inhibitor | Drug | Group C (Albumin-bound Paclitaxel and Immune Checkpoint Inhibitor Group), Group D (Albumin-bound Paclitaxel, Immune Checkpoint Inhibitor and Anti-angiogenic Therapy Group) |
| Anti-angiogenic drugAnti-angiogenic drug | Drug | Group B (Albumin-bound Paclitaxel and Anti-angiogenic Therapy Group), Group D (Albumin-bound Paclitaxel, Immune Checkpoint Inhibitor and Anti-angiogenic Therapy Group) |
| Trastuzumab emtansineTrastuzumab Emtansine | Drug | Group E (Albumin-bound Paclitaxel and Trastuzumab Emtansine Group) |
Primary outcome
objective response rate
Time frame: the duration from the date of randomization to any documented tumor progression or death due to any cause, assessed up to 12 months
The rate of complete response and partial response
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 5 Feb 2026.
- Individual participant dataSharing planned: Undecided. We would like to share data if request.
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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?
An observational study of Gastric Cancer and Second-line Treatment, run by Fudan 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 11 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 5 Feb 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.
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 Wanjing Feng (+86 021-64175590, 1915659989@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: the duration from the date of randomization to any documented tumor progression or death due to any cause, assessed up to 12 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 5 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.