Gastric CancerPhase 2NCT06222944
Anlotinib, TQB2450 (PD-L1 Inhibitor), and Albumin-bound Paclitaxel Regimens in the Treatment of GC/GEJA
A Phase 2 study testing Anlotinib, TQB2450 and Albumin-Bound Paclitaxel in people with Gastric Cancer and Adenocarcinoma of Esophagogastric Junction, run by Peking University at 1 site in China.
Trial summary
This study aims to assess the efficacy and safety of a combination therapy consisting of Anlotinib, TQB2450 (a PD-L1 inhibitor), and Albumin-bound Paclitaxel regimens in patients with advanced gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA) who have failed the previous treatment with Claudin18.2… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Adenocarcinoma of Esophagogastric Junction
- What is being tested?
- Anlotinib, TQB2450 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
- 90 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2024to 25 Aug 2026
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily join this study, sign the informed consent form, and have good compliance;
- Pathologically (histologically or cytologically) confirmed HER2/neu-negative (or HER2/neu status unclear) advanced gastric cancer or gastroesophageal junction adenocarcinoma;
- Patients who have failed first-line treatment with CLDN18.2-related regimen (CLDN18.2 drugs include CLDN18.2 monotherapy, CLDN18.2 dual therapy, CLDN18.2 ADC or CLDN18.2 CART therapy, treatment regimen includes CLDN18.2 combined with chemotherapy or immunotherapy or other systemic therapy) and the time from the end of the last treatment with CLDN18.2-related drugs is more than two weeks;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, at least one measurable lesion, which can be accurately measured in at least one direction (the maximum diameter needs to be recorded) by magnetic resonance imaging (MRI) or computed tomography (CT), with the longest diameter at baseline ≥10 mm (if it is a lymph node, the short diameter is required to be ≥15 mm); the measurable lesions should not have received local treatment such as radiotherapy (lesions in the previous radiotherapy area, if confirmed to have progressed and meet the RECIST 1.1 criteria, can also be selected as target lesions);
- Male or female patients aged ≥18 years and ≤75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0-1;
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- Expected survival ≥3 months;
- Adequate organ function, requiring the following laboratory test values at screening:
- Hemoglobin (HB) ≥80g/L (no blood transfusion within 14 days);
- Absolute neutrophil count (ANC) ≥1.5×109/L;
- Platelet count (PLT) ≥75×109/L (no use of interleukin 11 or TPO within 14 days);
- White blood cell count (WBC) ≥3.0×109/L (no use of granulocyte stimulating factor within 14 days).
- Serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);
- ALT and AST ≤2.5 ULN, if there is liver metastasis, then ALT and AST ≤5×ULN;
- Creatinine (Cr) ≤1.5 ULN or creatinine clearance rate (CCr) ≥60ml/min, (Cockcroft-Gault formula);
- Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
- Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);
- Cardiac enzyme spectrum: within normal range;
- Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after stopping the study treatment and must be non-lactating patients. Serum or urine pregnancy test negative within 7 days before enrollment in the study, or meet one of the following criteria to prove that there is no risk of pregnancy:
- a) Postmenopausal is defined as age over 50 years and amenorrhea for at least 12 months after stopping all exogenous hormone replacement therapy;
- b) Women under 50 years of age, if amenorrhea for 12 months or more after stopping all exogenous hormone therapy, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory postmenopausal reference range, can also be considered as postmenopausal;
- c) Have undergone irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but excluding bilateral tubal ligation; For men, they must agree to use appropriate methods of contraception or have undergone surgical sterilization during the trial and 8 weeks after the last administration of the trial drug;
Who cannot join
- For cohort 1, patients who have previously received anlotinib hydrochloride treatment or other anti-angiogenic small molecule tyrosine kinase inhibitors (TKIs) within 6 months. Patients who have stopped treatment with other anti-angiogenic small molecule TKIs for more than 6 months are allowed to enroll; For cohort 2 and cohort 3, patients who have received PD-L1 immune checkpoint inhibitor treatment in the first line are excluded, but patients who have received PD-1 or CTLA-4 immune checkpoint inhibitor treatment in the first line are allowed, if they have any of the following immune-related medical history and treatment history, they are excluded:
- Have any active autoimmune disease or history of autoimmune disease (such as but not limited to autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; requiring bronchodilators for medical intervention of asthma); but the following patients are allowed to enroll: vitiligo, psoriasis, alopecia that do not require systemic treatment, type I diabetes that is well controlled, hypothyroidism that has normal thyroid function after replacement therapy;
- Diagnosed with immunodeficiency or receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy (dose >10mg/day of prednisone or other equivalent hormones), and continuing to use it within 2 weeks before the first administration;
- Received any live vaccine, attenuated vaccine (including anti-infective vaccines, such as influenza vaccine, varicella vaccine, etc.), or inactivated vaccine within 4 weeks before enrollment and plan to receive live vaccine/attenuated vaccine/inactivated vaccine during the study; used systemic immunostimulants (including but not limited to interferon and IL-2) within 2 weeks before the start of the study treatment;
- For Cohort 3, patients who have previously received anlotinib hydrochloride or other anti-angiogenic small molecule tyrosine kinase inhibitors (TKIs) within 6 months. Patients who have stopped treatment with other anti-angiogenic small molecule TKIs for more than 6 months are allowed to enroll;
- Patients who have received anti-tumor treatment with traditional Chinese medicine within the past two weeks (the traditional Chinese medicine contains the following medicinal materials such as Brucea javanica, Coix seed, Lentinan, Cantharidin, Toad skin, Astragalus, Sophora, Ugonin, Chebula, Icariin, etc.), but patients who have stopped taking anti-tumor treatment with traditional Chinese medicine for more than two weeks are allowed to enroll;
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- Patients who have received ≥1 other systemic systemic anti-tumor treatment (including but not limited to chemotherapy, immunotherapy, targeted therapy, and other systemic treatment regimens) after failing CLDN18.2-related regimen treatment, but palliative local treatment (including radiotherapy and other local treatment regimens) for local lesions (non-target lesions) >two weeks later are allowed to enroll;
- Patients who have previously received allogeneic bone marrow transplantation or organ transplantation;
- Congenital pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia, or CT-confirmed active pneumonia;
- Patients with symptomatic central nervous system metastases and/or carcinomatous meningitis. Patients with a history of central nervous system metastases or spinal cord compression, if they have received treatment and stopped using anticonvulsants and steroids 4 weeks before the first administration of the study and have clinically stable performance, can enroll in the study;
- ≥ NCI CTCAE grade 2 peripheral neuropathy;
- Infection requiring antibiotics within 14 days before the start of the trial;
- Patients with bone metastases at risk of paraplegia;
- Patients with any severe and/uncontrolled disease, including:
- Patients with poor blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg); patients with grade II or higher myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥480ms); patients with III-IV heart failure according to NYHA criteria or cardiac ultrasound examination suggesting left ventricular ejection fraction (LVEF) <50%;
- Poorly controlled diabetes (fasting blood glucose (FBG) >10mmol/L);
- Urinalysis suggests urine protein ≥++, and 24-hour urine protein quantification >1.0 g is confirmed;
- Received major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks before the study, or expected to need major surgery during the study treatment, or non-diagnostic surgery within 4 weeks before the start of the trial;
- History of gastrointestinal perforation and/or fistula within 6 months before enrollment; or history of arterial/venous thromboembolic events, such as cerebrovascular accident (stable cerebral infarction excluded by researcher evaluation), deep vein thrombosis, and pulmonary embolism;
- Clinically significant pleural effusion, including any pleural effusion that can be found by physical examination, pleural effusion that has been treated in the past or still needs treatment. Patients with only a small amount of pleural effusion shown by imaging but no symptoms, and who do not need treatment according to the researcher's evaluation, can be enrolled;
- Body mass index (BMI) <17.0 kg/m² or weight loss of ≥10% within 2 months before screening;
- Patients with a history of psychotropic drug abuse and unable to quit or have mental disorders;
- Patients with active hepatitis B or hepatitis C, HIV-positive patients, patients with active tuberculosis;
- CT suggests definite ulcerative lesions, or occult blood in stool ++ or above;
- History of abnormal bleeding (except epistaxis) within 1 month before enrollment;
- History of other primary malignant tumors, except for the following: 1) Malignant tumors that have been completely remitted for at least 2 years before enrollment and do not require other treatment during the study; 2) Non-melanoma skin cancer or malignant melanocytic nevus that have been adequately treated and have no evidence of disease recurrence; 3) In situ carcinoma that has been adequately treated and has no evidence of disease recurrence;
- Pregnant or lactating female patients;
- According to the researcher's judgment, patients with severe accompanying diseases that endanger the patient's safety or affect the patient's completion of the study;
- Participated in other trials within 30 days before the start of the trial, or plan to participate in other trials during the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yakun Wang, PhD, 0086-010-88196340, wykun1991@126.com
About this study
Official title: A Multi-Center, Multi-Cohort Study of the Efficacy and Safety of Anlotinib, TQB2450, and Albumin-bound Paclitaxel in CLDN18.2-regimen-failed Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
This study aims to assess the efficacy and safety of a combination therapy consisting of Anlotinib, TQB2450 (a PD-L1 inhibitor), and Albumin-bound Paclitaxel regimens in patients with advanced gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA) who have failed the previous treatment with Claudin18.2 (CLDN18.2)-related regimens.
- Being tested
- Anlotinib, TQB2450, Albumin-Bound 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.
AnlotinibDrug
Also called Anlotinib Hydrochloride Capsule
Anlotinib: 12mg PO, QD, D1-14, Q3W;
TQB2450Drug
TQB2450: 1200 mg, IV, D1, Q3W
Albumin-Bound PaclitaxelDrug
Also called Paclitaxel (albumin-bound), Paclitaxel for injection(Albumin Bound)
125mg/m2 IV D1,8，Q3W
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib, TQB2450 and Albumin-bound Paclitaxel | Experimental | * Cohort 1: Anlotinib + albumin-bound paclitaxel;
* Cohort 2: TQB2450 + albumin-bound paclitaxel;
* Cohort 3: Anlotinib + TQB2450 + albumin-bound paclitaxel.
Anlotinib: 12mg PO, QD, D1-14, Q3W;
TQB2450: 1200 mg, IV, D1, Q3W;
Albumin-bound paclitaxel: 125mg/m2 IV Day 1,8, Q3W.
Until disease progression or intolerable toxicity or patient withdrawal of consent. Receives: Drug: Anlotinib; Drug: TQB2450; Drug: Albumin-Bound Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate (ORR) is defined as the percentage of participants who achieve either a complete response (CR) or a partial response (PR) according to the RECIST 1.1 criteria.
Measured: Baseline to CR/PR, about 12 months
Secondary outcomes (4)
DCR
Disease Control Rate (DCR) is defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD).
Measured: Baseline to CR/PR, about 16 months
PFS
Progression-free survival (PFS) is the time elapsed between treatment initiation and tumor progression or death from any cause based on the RECIST 1.1 criteria.
Measured: Baseline to CR/PR, about 16 months
OS
Overall Survival (OS) is defined as the time from the first dose of study drugs to the time of death from any cause.
Measured: Baseline to CR/PR, about 20 months
Adverse events
The adverse events (AEs) were assessed by investigators according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Baseline to CR/PR, about 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start25 Feb 2024 (estimated)
- Primary completion25 Aug 2025 (estimated)
- Study completion25 Aug 2026 (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 Peking 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Lin Shen, MD, PhD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222944
- Sponsor's protocol ID
- ALTER-GA001
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Multi-Cohort Study of the Efficacy and Safety of Anlotinib, TQB2450, and Albumin-bound Paclitaxel in CLDN18.2-regimen-failed Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06222944
- Acronym / sponsor ID
- ALTER-GA001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 25 Feb 2024 (estimated)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 25 Jan 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.
This study aims to assess the efficacy and safety of a combination therapy consisting of Anlotinib, TQB2450 (a PD-L1 inhibitor), and Albumin-bound Paclitaxel regimens in patients with advanced gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA) who have failed the previous treatment with Claudin18.2 (CLDN18.2)-related regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib, TQB2450 and Albumin-bound Paclitaxel | Experimental | Drug: Anlotinib, Drug: TQB2450, Drug: Albumin-Bound Paclitaxel* Cohort 1: Anlotinib + albumin-bound paclitaxel; * Cohort 2: TQB2450 + albumin-bound paclitaxel; * Cohort 3: Anlotinib + TQB2450 + albumin-bound paclitaxel. Anlotinib: 12mg PO, QD, D1-14, Q3W; TQB2450: 1200 mg, IV, D1, Q3W; Albumin-bound paclitaxel: 125mg/m2 IV Day 1,8, Q3W. Until disease progression or intolerable toxicity or patient withdrawal of consent. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Voluntarily join this study, sign the informed consent form, and have good compliance;
- Pathologically (histologically or cytologically) confirmed HER2/neu-negative (or HER2/neu status unclear) advanced gastric cancer or gastroesophageal junction adenocarcinoma;
- Patients who have failed first-line treatment with CLDN18.2-related regimen (CLDN18.2 drugs include CLDN18.2 monotherapy, CLDN18.2 dual therapy, CLDN18.2 ADC or CLDN18.2 CART therapy, treatment regimen includes CLDN18.2 combined with chemotherapy or immunotherapy or other systemic therapy) and the time from the end of the last treatment with CLDN18.2-related drugs is more than two weeks;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, at least one measurable lesion, which can be accurately measured in at least one direction (the maximum diameter needs to be recorded) by magnetic resonance imaging (MRI) or computed tomography (CT), with the longest diameter at baseline ≥10 mm (if it is a lymph node, the short diameter is required to be ≥15 mm); the measurable lesions should not have received local treatment such as radiotherapy (lesions in the previous radiotherapy area, if confirmed to have progressed and meet the RECIST 1.1 criteria, can also be selected as target lesions);
- Male or female patients aged ≥18 years and ≤75 years;
Key exclusion criteria (29 listed)
- For cohort 1, patients who have previously received anlotinib hydrochloride treatment or other anti-angiogenic small molecule tyrosine kinase inhibitors (TKIs) within 6 months. Patients who have stopped treatment with other anti-angiogenic small molecule TKIs for more than 6 months are allowed to enroll; For cohort 2 and cohort 3, patients who have received PD-L1 immune checkpoint inhibitor treatment in the first line are excluded, but patients who have received PD-1 or CTLA-4 immune checkpoint inhibitor treatment in the first line are allowed, if they have any of the following immune-related medical history and treatment history, they are excluded:
- For Cohort 3, patients who have previously received anlotinib hydrochloride or other anti-angiogenic small molecule tyrosine kinase inhibitors (TKIs) within 6 months. Patients who have stopped treatment with other anti-angiogenic small molecule TKIs for more than 6 months are allowed to enroll;
- Patients who have received anti-tumor treatment with traditional Chinese medicine within the past two weeks (the traditional Chinese medicine contains the following medicinal materials such as Brucea javanica, Coix seed, Lentinan, Cantharidin, Toad skin, Astragalus, Sophora, Ugonin, Chebula, Icariin, etc.), but patients who have stopped taking anti-tumor treatment with traditional Chinese medicine for more than two weeks are allowed to enroll;
- Patients who have received ≥1 other systemic systemic anti-tumor treatment (including but not limited to chemotherapy, immunotherapy, targeted therapy, and other systemic treatment regimens) after failing CLDN18.2-related regimen treatment, but palliative local treatment (including radiotherapy and other local treatment regimens) for local lesions (non-target lesions) >two weeks later are allowed to enroll;
- Patients who have 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 |
|---|---|---|
| AnlotinibAlso: Anlotinib Hydrochloride CapsuleAnlotinib: 12mg PO, QD, D1-14, Q3W; | Drug | Anlotinib, TQB2450 and Albumin-bound Paclitaxel |
| TQB2450TQB2450: 1200 mg, IV, D1, Q3W | Drug | Anlotinib, TQB2450 and Albumin-bound Paclitaxel |
| Albumin-Bound PaclitaxelAlso: Paclitaxel (albumin-bound), Paclitaxel for injection(Albumin Bound)125mg/m2 IV D1,8，Q3W | Drug | Anlotinib, TQB2450 and Albumin-bound Paclitaxel |
Primary outcome
ORR
Time frame: Baseline to CR/PR, about 12 months
Objective Response Rate (ORR) is defined as the percentage of participants who achieve either a complete response (CR) or a partial response (PR) according to the RECIST 1.1 criteria.
4 secondary outcomes
DCR
Time frame: Baseline to CR/PR, about 16 months
PFS
Time frame: Baseline to CR/PR, about 16 months
OS
Time frame: Baseline to CR/PR, about 20 months
Adverse events
Time frame: Baseline to CR/PR, about 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
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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.
Lin Shen, MD, PhD principal investigator
Peking University Cancer Hospital & Institute
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 Anlotinib, TQB2450 and Albumin-Bound Paclitaxel in people with Gastric Cancer and Adenocarcinoma of Esophagogastric Junction, run by Peking 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 22 inclusion and 29 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 25 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Shen (0086-010-88196340, Doctorshenlin@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Baseline to CR/PR, about 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 25 Jan 2024.