Gastric CancerNCT06417892
Fruquintinib and Albumin-paclitaxel Combined With or Without PD-1 Antibody in 2nd-line Treatment of G/GEJ Adenocarcinoma
An observational study of Gastric Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To explore the efficacy and safety of fruquintinib and albumin-paclitaxel combined with or without PD-1 antibody in the second-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma that failed to be treated by anti-PD-1 /PD-L1 regimen Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- PD-1inhibitor, Fruquintinib and albumin paclitaxel
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 30 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced gastric/gastroesophageal junction adenocarcinoma who failed treatment with anti-PD-1 /PD-L1 regimen.
Who may be able to join
- Have fully understood the study and voluntarily signed the informed consent;
- Age ≥18 years old;
- Pathologically confirmed advanced gastric/gastroesophageal junction adenocarcinoma with at least one systemic treatment;
- Frontline experienced exposure to immune drugs (including exposure to PD-1 drugs in the neoadjuvant, adjuvant, and systemic treatment stages; For patients with metastasis and recurrence within 6 months after the end of adjuvant/neoadjuvant system treatment, the above-mentioned treatment is first-line treatment);
- ECOG's physical condition was 0-1, and did not deteriorate within 7 days;
- BMI≥18;
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- Expected survival ≥3 months;
- The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors is not allowed within the first 14 days of enrollment) a) Absolute neutrophil count ≥1.5×109/L, white blood cell ≥4.0×109/L; b) Platelet ≥100×109/L; c) Hemoglobin ≥90g/L; d) Total bilirubin TBIL≤1.5 times ULN; e)ALT and AST≤2.5 times ULN (up to 5 times in patients with liver metastasis); f) Urea/urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN (and creatinine clearance (CCr) ≥ 50mL/min); g) Left ventricular ejection fraction (LVEF) ≥50%; h)Fridericia's corrected QT interval (QTcF) <470 ms. i) INR≤1.5 x ULN, APTT≤1.5 x ULN.
- Women of childbearing age need to take effective contraceptive measures;
- Good compliance, cooperate with follow-up;
Who cannot join
- Failure to comply with the study protocol or study procedure;
- Previous treatment with VEGFR inhibitors;
- Previously received paclitaxel therapy (except for those who received paclitaxel therapy in neoadjuvant or adjuvant therapy, and the treatment ended more than 6 months after the progression of the disease);
- Known HER-2 positive patients;
- Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;
- Had other malignancies within 5 years prior to enrollment, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
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- Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
- Previously received allogeneic bone marrow transplantation or organ transplantation;
- Subjects who are allergic to the investigational drug or any of its adjuncts;
- Electrolyte abnormalities identified by the investigator as clinically significant;
- Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
- Had any disease or condition affecting drug absorption before enrollment, or the patient could not take the drug orally;
- Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresectable tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;
- Patients with significant evidence or history of bleeding tendency (hemorrhage >30 mL within 3 months, accompanied by hematemesis, stool, and blood in the stool), hemoptysis (>5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months prior to enlistment;
- Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; Congestive heart failure New York Heart Association (NYHA) Grade >2; Ventricular arrhythmias requiring medical treatment; LVEF (left ventricular ejection fraction) <50%;
- Active or uncontrolled severe infection (≥CTCAE v5.0 grade 2 infection);
- Known human immunodeficiency virus (HIV) infection. A known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., positive HBV DNA (>1×104 copies /mL or >2000 IU/ml) must be excluded for a known hepatitis B virus (HBV) carrier; Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL);
- Unmitigated toxicity higher than CTCAE v5.0 grade 1 due to any previous anticancer therapy, excluding alopecia, lymphocytopenia, and oxaliplatin grade ≤2 neurotoxicity;
- Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- Received blood transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), within 28 days before enrollment;
- Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk;
- Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume >1.0g;
- The patients considered by the investigators to be unsuitable for inclusion in this study.
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
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
LIN YANG, Doctor, 010-8778-8145, linyangcicams@126.com
About this study
Official title: A Randomized Controlled Study of 2nd-line Treatment of Advanced G/GEJ Adenocarcinoma With Fruquintinib and Albumin-paclitaxel in Combination With or Without PD-1 Antibody in Patients Who Have Failed Treatment With PD-1 Antibody
To explore the efficacy and safety of fruquintinib and albumin-paclitaxel combined with or without PD-1 antibody in the second-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma that failed to be treated by anti-PD-1 /PD-L1 regimen
Read the detailed description
This is a single-center, prospective, open, randomized controlled study of patients with advanced second-line gastric/gastroesophageal junction adenocarcinoma. The study population was pathologically confirmed advanced gastric/gastroesophageal junction adenocarcinoma, which had undergone one systemic treatment; First-line exposure to immune drugs (including PD-1 drug exposure at the stage of neoadjuvant, adjuvant, and systemic therapy); For patients with metastasis and recurrence within 6 months after the end of adjuvant/neoadjuvant system treatment, the above-mentioned treatment is first-line treatment). After patients meeting the inclusion criteria signed informed consent, the study was observed from the start of treatment until death, withdrawal of informed consent, loss of follow-up, or the end of the study.
Eligible subjects will be randomly assigned to either fruquintinib combined with albumin-paclitaxel or fruquintinib combined with albumin-paclitaxel combined with PD-1 monoclonal antibody in a 1:1 ratio. A total of 60 subjects are planned to enter the study treatment, 30 in each treatment group, and enter one of the following open treatment groups:
Group A: Fruquintinib combined with albumin-paclitaxel regimen Group B: Fruquintinib, albumin-paclitaxel combined with PD-1 antibody regimen For enrolled patients, the treating physician conducted the first visit before treatment, and the follow-up visit and the last visit after treatment began. Visits were conducted in accordance with clinical norms and there was no fixed schedule for visits. Physicians collect demographic and disease-related baseline data from medical records or at the first visit prior to treatment. Treatment-related data, including adverse events and tumor status, were collected during follow-up visits. Survival follow-up was conducted every 3 months after the end of the study, either by phone, wechat or through other doctors. The last visit recorded patient death, withdrawal of informed consent, loss of visit, or end of study.
- Conditions
- Gastric Cancer
- Being tested
- PD-1inhibitor, Fruquintinib, albumin paclitaxel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1inhibitorDrug
Also called PD-1 antibody
PD-1 antibody was selected according to first-line drug use
FruquintinibDrug
a small molecular anti-tumor angiogensis drug
albumin paclitaxelDrug
Also called nab-paclitaxel
a kind of cytotoxic chemotherapy drug
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib + albumin paclitaxel | Fruquintinib combined with albumin paclitaxel Receives: Drug: Fruquintinib; Drug: albumin paclitaxel | |
| Fruquintinib + albumin paclitaxel + PD-1 antibody | Fruquintinib, albumin paclitaxel combined with PD-1 antibody Receives: Drug: PD-1inhibitor; Drug: Fruquintinib; Drug: albumin paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: 2 years
Secondary outcomes (5)
ORR
Objective Remission Rate
Measured: 2 years
DCR
Disease Control Rate
Measured: 2 years
DoR
Duration of Remission
Measured: 2 years
OS
overall survival
Measured: 2 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events and its degree
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start15 Apr 2024
- Primary completion31 May 2027 (estimated)
- Study completion30 Dec 2027 (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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIN YANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- LIN YANG, Doctor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417892
- Sponsor's protocol ID
- NCC4594
- Status last verified
- Jul 2026
- First submitted
- 13 May 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of 2nd-line Treatment of Advanced G/GEJ Adenocarcinoma With Fruquintinib and Albumin-paclitaxel in Combination With or Without PD-1 Antibody in Patients Who Have Failed Treatment With PD-1 Antibody
- ClinicalTrials.gov ID
- NCT06417892
- Acronym / sponsor ID
- NCC4594
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the efficacy and safety of fruquintinib and albumin-paclitaxel combined with or without PD-1 antibody in the second-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma that failed to be treated by anti-PD-1 /PD-L1 regimen
Detailed description
This is a single-center, prospective, open, randomized controlled study of patients with advanced second-line gastric/gastroesophageal junction adenocarcinoma. The study population was pathologically confirmed advanced gastric/gastroesophageal junction adenocarcinoma, which had undergone one systemic treatment; First-line exposure to immune drugs (including PD-1 drug exposure at the stage of neoadjuvant, adjuvant, and systemic therapy); For patients with metastasis and recurrence within 6 months after the end of adjuvant/neoadjuvant system treatment, the above-mentioned treatment is first-line treatment). After patients meeting the inclusion criteria signed informed consent, the study was observed from the start of treatment until death, withdrawal of informed consent, loss of follow-up, or the end of the study.
Eligible subjects will be randomly assigned to either fruquintinib combined with albumin-paclitaxel or fruquintinib combined with albumin-paclitaxel combined with PD-1 monoclonal antibody in a 1:1 ratio. A total of 60 subjects are planned to enter the study treatment, 30 in each treatment group, and enter one of the following open treatment groups:
Group A: Fruquintinib combined with albumin-paclitaxel regimen Group B: Fruquintinib, albumin-paclitaxel combined with PD-1 antibody regimen For enrolled patients, the treating physician conducted the first visit before treatment, and the follow-up visit and the last visit after treatment began. Visits were conducted in accordance with clinical norms and there was no fixed schedule for visits. Physicians collect demographic and disease-related baseline data from medical records or at the first visit prior to treatment. Treatment-related data, including adverse events and tumor status, were collected during follow-up visits. Survival follow-up was conducted every 3 months after the end of the study, either by phone, wechat or through other doctors. The last visit recorded patient death, withdrawal of informed consent, loss of visit, or end of study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib + albumin paclitaxel | – | Drug: Fruquintinib, Drug: albumin paclitaxelFruquintinib combined with albumin paclitaxel |
| Fruquintinib + albumin paclitaxel + PD-1 antibody | – | Drug: PD-1inhibitor, Drug: Fruquintinib, Drug: albumin paclitaxelFruquintinib, albumin paclitaxel combined with PD-1 antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced gastric/gastroesophageal junction adenocarcinoma who failed treatment with anti-PD-1 /PD-L1 regimen.
Key inclusion criteria (10 listed)
- Have fully understood the study and voluntarily signed the informed consent;
- Age ≥18 years old;
- Pathologically confirmed advanced gastric/gastroesophageal junction adenocarcinoma with at least one systemic treatment;
- Frontline experienced exposure to immune drugs (including exposure to PD-1 drugs in the neoadjuvant, adjuvant, and systemic treatment stages; For patients with metastasis and recurrence within 6 months after the end of adjuvant/neoadjuvant system treatment, the above-mentioned treatment is first-line treatment);
- ECOG's physical condition was 0-1, and did not deteriorate within 7 days;
Key exclusion criteria (23 listed)
- Failure to comply with the study protocol or study procedure;
- Previous treatment with VEGFR inhibitors;
- Previously received paclitaxel therapy (except for those who received paclitaxel therapy in neoadjuvant or adjuvant therapy, and the treatment ended more than 6 months after the progression of the disease);
- Known HER-2 positive patients;
- Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;
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 |
|---|---|---|
| PD-1inhibitorAlso: PD-1 antibodyPD-1 antibody was selected according to first-line drug use | Drug | Fruquintinib + albumin paclitaxel + PD-1 antibody |
| Fruquintiniba small molecular anti-tumor angiogensis drug | Drug | Fruquintinib + albumin paclitaxel, Fruquintinib + albumin paclitaxel + PD-1 antibody |
| albumin paclitaxelAlso: nab-paclitaxela kind of cytotoxic chemotherapy drug | Drug | Fruquintinib + albumin paclitaxel, Fruquintinib + albumin paclitaxel + PD-1 antibody |
Primary outcome
PFS
Time frame: 2 years
Progression free survival
5 secondary outcomes
ORR
Time frame: 2 years
DCR
Time frame: 2 years
DoR
Time frame: 2 years
OS
Time frame: 2 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 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 28 Jul 2026.
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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.
LIN YANG, Doctor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 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 28 Jul 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 LIN YANG, Doctor (010-87788145, linyangcicams@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 2 years). 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 28 Jul 2026.