Gastric CancerNCT06102759
Adebrelimab and Fruquintinib Combined With Paclitaxel/Albumin Paclitaxel for Advanced Gastric Cancer After PD-1 Antibody Failed
An observational study of Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a prospective, single-center, open, single-arm clinical study to observe and evaluate the efficacy and safety of Fruquintinib and Adebrelimab combined with paclitaxel/albumin paclitaxel for second-line treatment of advanced gastric cancer. 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?
- Adebrelimab，Fruquintinib
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2023to 10 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Advanced gastric cancer that failed first-line treatment with PD1 antibody
Who may be able to join
- Age ≥18 years old.
- The ECOG score is 0-1 and does not deteriorate within 7 days.
- Patients with histologically confirmed, metastatic, or unresectable locally advanced gastric cancer or GEJ adenocarcinoma.
- Previously received one systemic chemotherapy regimen for this cancer and progressed; Or have received adjuvant chemotherapy, but have disease progression or recurrence within 6 months after the end of treatment.
- First-line exposure to PD-1 antibodies and first-line treatment of PFS greater than 9 months.
- Measurable lesions that meet RECIST 1.1 criteria.
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- Have adequate organ and bone marrow function, laboratory tests meet the following requirements:
- HGB≥90g/L;
- NEUT≥1.5×10^9/L;
- PLT ≥80×10^9/L;
- TBIL≤1.5 times upper limit of normal value (ULN);
- ALT and AST≤2.5 x ULN; In liver metastasis, ALT and AST≤5×ULN;
- Endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula);
- Urinary protein \< (++), or 24-hour urinary protein volume \< 1.0 g.
- Normal coagulation function, no active bleeding
- International standardized ratio INR≤1.5;
- Partial thromboplastin time APTT≤1.5 ULN.
- Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 14 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and within 8 weeks after the last dose of the study drug; For men, they should be surgically sterilized or consent to an appropriate method of contraception during the observation period and for 8 weeks after the last administration of the study drug.
- Expected survival ≥3 months.
- Patients voluntarily joined the study and signed an informed consent form (ICF).
- It is expected that the compliance is good, and the efficacy and adverse reactions can be followed up according to the protocol requirements.
Who cannot join
- 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 disease progression);
- Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;
- Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
- Previously received allogeneic bone marrow transplantation or organ transplantation;
- 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;
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- Had any disease or condition affecting drug absorption before enrollment, or the patient could not take drugs orally;
- Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unexcised tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;
- Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months \> 30 mL, hematemesis, stool, stool blood), hemoptysis, or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months;
- 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; New York Heart Association (NYHA) Grades for Congestive Heart Failure \> Level 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. Known history of clinically significant liver disease, including viral hepatitis [Known hepatitis B virus (HBV) carriers must rule out active HBV infection, i.e., positive HBV DNA (\>1×104 copies /mL or \> 2000 IU/ mL); known hepatitis C virus infection (HCV) and HCV RNA positive (\>1×103 copies /mL);
- 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;
- The patients considered by the investigators to be unsuitable for inclusion in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Ting Deng, MD, 022-23340123-1051, xymcdengting@126.com
About this study
Official title: Phase II Clinical Study of Adebrelimab and Fruquintinib Combined With Paclitaxel/Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer After First-line Treatment With PD-1 Antibody Failed
This is a prospective, single-center, open, single-arm clinical study to observe and evaluate the efficacy and safety of Fruquintinib and Adebrelimab combined with paclitaxel/albumin paclitaxel for second-line treatment of advanced gastric cancer.
Read the detailed description
Since the first-line ICIs application of gastric cancer is mainly PD-1 antibody, this study intends to screen first-line patients exposed to PD-1 antibody and with long survival (PFS longer than 9 months) to receive second-line PD-L1 antibody for re-challenge and combine with Fruquintinib and paclitaxel to explore whether it can further increase the effect of second-line treatment.
- Conditions
- Gastric Cancer
- Being tested
- Adebrelimab，Fruquintinib
- Keywords
- gastric cancer, second-line treatment, Adebrelimab, Fruquintinib, chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab，FruquintinibDrug
Adebrelimab，Fruquintinib combined with chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab, Fruquintinib combined with paclitaxel | Fruquintinib 4mg d1-14, q3w Paclitaxel 150mg/m2, d1, q3w / Albumin paclitaxel 125mg/m2, d1, d8, q3w PD-L1 antibody (Adebrelimab) 20 mg/kg, d1, q3w Receives: Drug: Adebrelimab，Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Time from the start of treatment to the progression of the disease
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcomes (3)
Disease Control rate
The proportion of CR,PR and SD
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
The Overall Response Rate
The proportion of CR and PR
Measured: Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival
Time from the start of treatment to the occurrence of death
Measured: From date of randomization until the date of death from any cause or the last visit date, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start10 Nov 2023 (estimated)
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ting Deng, MD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102759
- Sponsor's protocol ID
- TJMUCH-GI-GC04
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
1. Sharma P, Hu-Lieskovan S, Wargo JA, et al. Primary, Adaptive, and Acquired Resistance toCancer Immunotherapy. Cell 2017; 168: 707-723. 2. Teng MW, Ngiow SF, Ribas A, et al. Classifying Cancers Based on T-cell Infiltration and PD-L1.Cancer Res 2015; 75: 2139-45. 3. Olson DJ, Eroglu Z, Brockstein B, et al. Pembrolizumab Plus Ipilimumab Following Anti-PD1/L1 Failure in Melanoma. J Clin Oncol 2021; 39: 2647-2655. 4. Pires da Silva I, Ahmed T, Reijers ILM, et al. Ipilimumab alone or ipilimumab plus anti-PD-1therapy in patients with metastatic melanoma resistant to anti-PD-(L)1 monotherapy: a multicentre,retrospective, cohort study. Lancet Oncol 2021; 22: 836-847. 5. Zaremba A, Eggermont AMM, Robert C, et al. The concepts of rechallenge and retreatmentwith immune checkpoint blockade in melanoma patients. Eur J Cancer 2021; 155: 268-280. 6. Yang K, Li J, Sun Z, et al. Retreatment with immune checkpoint inhibitors in solid tumors: asystematic review. Ther Adv Med Oncol 2020; 12: 1758835920975353. 7. Vera Aguilera J, Paludo J, McWilliams RR, et al. Chemo-immunotherapy combination afterPD-1 inhibitor failure improves clinical outcomes in metastatic melanoma patients. Melanoma Res2020; 30: 364-375. 8. Giaj Levra M, Cotte FE, Corre R, et al. Immunotherapy rechallenge after nivolumabtreatment in advanced non-small cell lung cancer in the real-world setting: A national data baseanalysis. Lung Cancer 2020; 140: 99-106. 9. Kitagawa S, Hakozaki T, Kitadai R, et al. Switching administration of anti-PD-1 and anti-PD-L1antibodies as immune checkpoint inhibitor rechallenge in individuals with advanced non-small celllung cancer: Case series and literature review. Thorac Cancer 2020; 11: 1927-1933. 10. Takahara Y, Tanaka T, Ishige Y, et al. Efficacy and predictors of rechallenge with immunecheckpoint inhibitors in non-small cell lung cancer. Thorac Cancer 2022; 13: 624-630. 11. Zhang Y, Wang ZX, Shen L, et al. A phase Ib/II study of fruquintinib in combination withpaclitaxel as the second-line therapy for advanced gastric cancer. Cancer Commun (Lond) 2023; 43:150-153.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Adebrelimab and Fruquintinib Combined With Paclitaxel/Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer After First-line Treatment With PD-1 Antibody Failed
- ClinicalTrials.gov ID
- NCT06102759
- Acronym / sponsor ID
- TJMUCH-GI-GC04
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, second-line treatment, Adebrelimab, Fruquintinib, chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 10 Nov 2023 (estimated)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-center, open, single-arm clinical study to observe and evaluate the efficacy and safety of Fruquintinib and Adebrelimab combined with paclitaxel/albumin paclitaxel for second-line treatment of advanced gastric cancer.
Detailed description
Since the first-line ICIs application of gastric cancer is mainly PD-1 antibody, this study intends to screen first-line patients exposed to PD-1 antibody and with long survival (PFS longer than 9 months) to receive second-line PD-L1 antibody for re-challenge and combine with Fruquintinib and paclitaxel to explore whether it can further increase the effect of second-line treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab, Fruquintinib combined with paclitaxel | – | Drug: Adebrelimab，FruquintinibFruquintinib 4mg d1-14, q3w Paclitaxel 150mg/m2, d1, q3w / Albumin paclitaxel 125mg/m2, d1, d8, q3w PD-L1 antibody (Adebrelimab) 20 mg/kg, d1, q3w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced gastric cancer that failed first-line treatment with PD1 antibody
Key inclusion criteria (21 listed)
- Age ≥18 years old.
- The ECOG score is 0-1 and does not deteriorate within 7 days.
- Patients with histologically confirmed, metastatic, or unresectable locally advanced gastric cancer or GEJ adenocarcinoma.
- Previously received one systemic chemotherapy regimen for this cancer and progressed; Or have received adjuvant chemotherapy, but have disease progression or recurrence within 6 months after the end of treatment.
- First-line exposure to PD-1 antibodies and first-line treatment of PFS greater than 9 months.
Key exclusion criteria (14 listed)
- 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 disease progression);
- Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;
- Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
- Previously received allogeneic bone marrow transplantation or organ transplantation;
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 |
|---|---|---|
| Adebrelimab，FruquintinibAdebrelimab，Fruquintinib combined with chemotherapy | Drug | Adebrelimab, Fruquintinib combined with paclitaxel |
Primary outcome
Progression Free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Time from the start of treatment to the progression of the disease
3 secondary outcomes
Disease Control rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
The Overall Response Rate
Time frame: Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival
Time frame: From date of randomization until the date of death from any cause or the last visit date, whichever came first, assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Results publication1. Sharma P, Hu-Lieskovan S, Wargo JA, et al. Primary, Adaptive, and Acquired Resistance toCancer Immunotherapy. Cell 2017; 168: 707-723. 2. Teng MW, Ngiow SF, Ribas A, et al. Classifying Cancers Based on T-cell Infiltration and PD-L1.Cancer Res 2015; 75: 2139-45. 3. Olson DJ, Eroglu Z, Brockstein B, et al. Pembrolizumab Plus Ipilimumab Following Anti-PD1/L1 Failure in Melanoma. J Clin Oncol 2021; 39: 2647-2655. 4. Pires da Silva I, Ahmed T, Reijers ILM, et al. Ipilimumab alone or ipilimumab plus anti-PD-1therapy in patients with metastatic melanoma resistant to anti-PD-(L)1 monotherapy: a multicentre,retrospective, cohort study. Lancet Oncol 2021; 22: 836-847. 5. Zaremba A, Eggermont AMM, Robert C, et al. The concepts of rechallenge and retreatmentwith immune checkpoint blockade in melanoma patients. Eur J Cancer 2021; 155: 268-280. 6. Yang K, Li J, Sun Z, et al. Retreatment with immune checkpoint inhibitors in solid tumors: asystematic review. Ther Adv Med Oncol 2020; 12: 1758835920975353. 7. Vera Aguilera J, Paludo J, McWilliams RR, et al. Chemo-immunotherapy combination afterPD-1 inhibitor failure improves clinical outcomes in metastatic melanoma patients. Melanoma Res2020; 30: 364-375. 8. Giaj Levra M, Cotte FE, Corre R, et al. Immunotherapy rechallenge after nivolumabtreatment in advanced non-small cell lung cancer in the real-world setting: A national data baseanalysis. Lung Cancer 2020; 140: 99-106. 9. Kitagawa S, Hakozaki T, Kitadai R, et al. Switching administration of anti-PD-1 and anti-PD-L1antibodies as immune checkpoint inhibitor rechallenge in individuals with advanced non-small celllung cancer: Case series and literature review. Thorac Cancer 2020; 11: 1927-1933. 10. Takahara Y, Tanaka T, Ishige Y, et al. Efficacy and predictors of rechallenge with immunecheckpoint inhibitors in non-small cell lung cancer. Thorac Cancer 2022; 13: 624-630. 11. Zhang Y, Wang ZX, Shen L, et al. A phase Ib/II study of fruquintinib in combination withpaclitaxel as the second-line therapy for advanced gastric cancer. Cancer Commun (Lond) 2023; 43:150-153.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ting Deng, MD principal investigator
Tianjin Medical University Cancer Institute and Hospital
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 Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 26 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Deng, MD (022-23340123 ext. 1051, xymcdengting@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06102759, which also lists 1 linked publication.
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 26 Oct 2023.