Gastric/Gastroesophageal Junction AdenocarcinomaPhase 2NCT06415669

A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing Paclitaxel for injection (albumin-bound), Adebrelimab and Apatinib mesylate in people with Gastric/Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital of Xiamen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

To evaluate the initial efficacy and safety of paclitaxel for injection (albumin-bound) in combination with apatinib mesylate and adebrelimab in the treatment of locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma following the progression of previous immunotherapy. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastric/Gastroesophageal Junction Adenocarcinoma
What is being tested?: Paclitaxel for injection (albumin-bound), Adebrelimab and Apatinib mesylate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 19 May 2024to 19 May 2027
Phase: Phase 2
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1) Age: 18 ~ 75 years old, male and female;
2) ECOG score: 0 or 1;
3) Patients with unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma confirmed by histopathology;
4) Patients who have received at least first-line immunotherapy progression or intolerance in the past, and the number of previous systemic treatment lines does not exceed 2 lines; The best curative effect of frontline containing PD-1/PD-L1 was CR, PR or SD;
5) According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located in the area of previous radiotherapy can also be selected as target lesions if progression is confirmed);
6) The major organs function normally and meet the following criteria

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a. In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) ≥1.5x109 /L;
b. Platelets ≥100×109 /L in the past 14 days without blood transfusion;
c. Hemoglobin >90g/L in the last 14 days without blood transfusion or use of erythropoietin;
d. Total bilirubin ≤1.5× upper limit of normal (ULN);
e. aspartate aminotransferase (AST), alanine aminotransferase (ALT) in
≤2.5×ULN (ALT or AST ≤5×ULN for patients with liver metastasis);
f. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥40 ml/min;
g. Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
h. The myocardial enzyme profile is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality is not clinically significant, it is also allowed to be included);
7) Expected survival ≥3 months;
8) Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period;
9) Sign informed consent.

Who cannot join

1) Patients who have previously received paclitaxel chemotherapy; Patients with neoadjuvant or adjuvant treatment with taxoid drugs and disease progression more than 6 months after the last chemotherapy were excluded;
2) HER2-positive patients;
3) Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks before enrollment;
4) Patients with severe liver and kidney insufficiency or heart insufficiency;
5) have multiple factors that affect oral drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea, and intestinal obstruction);
6) Patients with brain metastases accompanied by symptoms or symptom control for less than 3 months;

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7) Patients who are known to be allergic to any investigational drug or drug excipient;
8) Pregnant or lactating female patients;
9) Patients who underwent major surgical procedures (craniotomy, thoracotomy, or laparotomy) or had unhealed surgical wounds, ulcers, or fractures within 4 weeks prior to initial dosing, except for patients ≥2 weeks after surgery and patients with old fractures that the investigator determined could be treated with the study drug;
10) Patients with moderate to severe ascites accompanied by clinical symptoms requiring repeated drainage; Patients with uncontrolled or clinical symptoms of pleural effusion or pericardial effusion;
11) Patients with clinically significant electrolyte disorders;
12) People with acute or chronic active hepatitis B or hepatitis C: hepatitis B virus (HBV) DNA > 2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA > 103 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive patients;
13) Patients with central nervous system metastasis, but with no clinical symptoms or accompanied by clinical symptoms after treatment, disease control and stable time ≥4 weeks can be enrolled; To meet the need for measurable lesions outside the central nervous system, hormone therapy should be discontinued 14 days before the first study of medication
14) Any life-threatening bleeding event within the previous 3 months, including patients requiring transfusion therapy, surgery or local therapy, and ongoing medication;
15) Patients with a history of arteriovenous thromboembolism events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other severe thromboembolism within the past 6 months. The exception is implantable intravenous infusion port or catheter-derived thrombosis, or superficial venous thrombosis, which is stable after conventional anticoagulant therapy. Allow patients to prophylactically use small doses of low molecular weight heparin (e.g., enoxaparin 40 mg/ day);
16) Uncontrolled hypertension, systolic blood pressure > 160 MMHG or diastolic blood pressure > 100mmHg after optimal medical treatment, hypertensive crisis or hypertensive encephalopathy history;
17) Symptomatic congestive heart failure (New York Heart Association Grade II-IV). Symptomatic or poorly controlled arrhythmia. Patients with a history of congenital long QT syndrome or a QTc > 500ms (calculated using the Fridericia method) corrected at screening;
18) For patients who received radiation therapy more than 4 weeks before the first treatment, all of the following conditions must be met to be enrolled: there is no current toxic reaction related to radiation therapy, no need to take glucocorticoids, and radiation pneumonia, radiation hepatitis, and radiation enteritis are excluded;
19) Patients with previous or current pulmonary diseases such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and severe impairment of lung function;
20) Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), known syphilis infection;
21) Patients with unhealed wounds, fractures, gastric and duodenal ulcers, persistent positive stool occultiblood, ulcerative colitis, or other conditions that researchers have determined may cause gastrointestinal bleeding or perforation;
22) All adverse events during the screening period have not returned to baseline or ≤ Grade 1 (NCI-CTCAE V5.0) (except for alopecia, or peripheral sensory neuropathy, which can be grade 2);
23) Patients with severe infections that are active or poorly controlled clinically. Patients with severe infections in the 4 weeks prior to initial dosing, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia;
24) Use of immunosuppressive drugs within 4 weeks prior to initial administration, excluding nasal, inhaled, or other routes of topical corticosteroids or physiological doses of systemic corticosteroids (i.e., no more than 10mg/ day of prednisone or equivalent doses of other corticosteroids); To allow temporary use of glucocorticoids for the treatment of breathing difficulties in diseases such as asthma and chronic obstructive pulmonary disease;
25) Patients who received live attenuated vaccine within 4 weeks prior to initial administration or who planned to receive live attenuated vaccine during the study period;
26) Patients who received major surgical treatment or significant traumatic injury 4 weeks prior to initial dosing
27) Patients who received traditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first dose;
28) Patients with a history of gastrointestinal perforation or abscess within 6 months prior to enrollment;
29) Received treatment in other clinical trials within 4 weeks prior to initial dosing;
30) Patients whose urine routine indicated urinary protein ≥2+, or 24-hour urinary protein quantity >1.0g;
31) The presence of any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis); Patients with asthma requiring medical intervention with bronchodilators were not included); However, the following patients were admitted: vitiligo, psoriasis, alopecia, well-controlled type I diabetes without systemic therapy, hypothyroidism with normal thyroid function treated by replacement therapy;
32) Other acute or chronic medical conditions, psychiatric disorders, or abnormalities in laboratory test values that may contribute to these results: increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and, in the investigator's judgment, classify patients as ineligible to participate in the study;
33) Other situations deemed unsuitable for inclusion by the researcher.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mingquan Cai contact

13696908231

mingquan035@163.com

China1 site, 1 recruiting

The First Affiliated Hospital of Xiamen University
Fuzhou, Fujian
Mingquan Cai, 13696908231, mingquan035@163.com
Recruiting

Other trials in China

About this study

Official title: A Study of Paclitaxel (Albumin-bound) Combined With Apatinib and Adebrelimab in the Treatment of Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma Following Previous Immunotherapy Progression

Conditions: Gastric/Gastroesophageal Junction Adenocarcinoma
Being tested: Paclitaxel for injection (albumin-bound), Adebrelimab, Apatinib mesylate
Keywords: paclitaxel, apatinib, adebrelimab, adenocarcinoma of the gastroesophageal junction, gastric carcinoma
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Paclitaxel for injection (albumin-bound)Drug
100 mg/m2, day 1, day 8, every 21 days for a cycle.
AdebrelimabDrug
Also called SHR-1316
20mg/kg or 1200mg, the first day, every 21 days as a cycle.
Apatinib mesylateDrug
250mg once a day for 5 consecutive days and discontinue for 2 days

Study groups in NCT06415669
Study group	Role	What they receive
Single arm	Experimental	Paclitaxel for injection (albumin-bound) in combination with Apatinib mesylate and adebrelimab Receives: Drug: Paclitaxel for injection (albumin-bound); Drug: Adebrelimab; Drug: Apatinib mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective response rate（ORR）
Refers to the proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to RECIST 1.1 criteria.
Measured: 1 years

Secondary outcomes (6)

Disease control rate（DCR）
Refers to the proportion of all subjects with the best overall response (BOR) according to RECIST1.1 criteria as complete remission (CR), partial remission (PR) and stable disease (SD).
Measured: 1 years
Progression-free survival (PFS)
PFS was defined as the subject's date from the date of the first dose to the date of the first documented tumor progression (as assessed by RECIST1.1 criteria, with or without continuation of treatment) or the date of death from any cause, whichever occurred first.
Measured: 1 years
Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR)
It refers to the time between the first evaluation of a tumor as CR or PR and the second evaluation as Progressive Disease (PD) or death from any cause.
Measured: 1 years
Overall survival（OS）
Defined as the time from the date of the first dose to the death of the subject from any cause.
Measured: 2 years
Occurence of AE and SAE
Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）
Measured: 2 years
Appraisal of life quality
Quality of life scale for cancer patients(The EORTC's QLQ-C30 (V3.0)) is a core scale for all cancer patients with 30 entries.Items 29 and 30 are divided into seven grades, ranging from 1 to 7 according to their answer choices; Other items are rated on a four-point scale,with a straightforward scale of 1 to 4.Except for items 29 and 30, they are all reverse entries (the larger the value, the worse the quality of life).The score for each field is obtained by adding and dividing the scores for the items included in each field by the number of items included (RS).The standard component of the computing function area also changes direction. Specifically, it is calculated according to the following formula (where R is the score range of each field or item).Functional area: SS=[1-(RS-1)/R]*100 Symptom domain and general health status domain :SS=[(RS-1)/R]*100
Measured: 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 May 202419 May 2027

First posted16 May 2024
Study start19 May 2024
Primary completion19 May 2026 (estimated)
Study completion19 May 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastric/Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
More trials run by The First Affiliated Hospital of Xiamen 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: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06415669
Sponsor's protocol ID: 23-OBU-FJ-GC-II-013
Status last verified: May 2024
First submitted: 27 Apr 2024
Last updated: 29 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Mingquan Cai

13696908231

mingquan035@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 2
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Stomach Neoplasms
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma

All Gastric/Gastroesophageal Junction Adenocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Paclitaxel (Albumin-bound) Combined With Apatinib and Adebrelimab in the Treatment of Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma Following Previous Immunotherapy Progression
ClinicalTrials.gov ID: NCT06415669
Acronym / sponsor ID: 23-OBU-FJ-GC-II-013
Conditions: Gastric/Gastroesophageal Junction Adenocarcinoma
Keywords: paclitaxel, apatinib, adebrelimab, adenocarcinoma of the gastroesophageal junction, gastric carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
Study start: 19 May 2024 (actual)
Primary completion: 19 May 2026 (estimated)
Study completion: 19 May 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single arm	Experimental	Drug: Paclitaxel for injection (albumin-bound), Drug: Adebrelimab, Drug: Apatinib mesylatePaclitaxel for injection (albumin-bound) in combination with Apatinib mesylate and adebrelimab

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

1) Age: 18 ~ 75 years old, male and female;
2) ECOG score: 0 or 1;
3) Patients with unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma confirmed by histopathology;
4) Patients who have received at least first-line immunotherapy progression or intolerance in the past, and the number of previous systemic treatment lines does not exceed 2 lines; The best curative effect of frontline containing PD-1/PD-L1 was CR, PR or SD;
5) According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located in the area of previous radiotherapy can also be selected as target lesions if progression is confirmed);

Key exclusion criteria (33 listed)

1) Patients who have previously received paclitaxel chemotherapy; Patients with neoadjuvant or adjuvant treatment with taxoid drugs and disease progression more than 6 months after the last chemotherapy were excluded;
2) HER2-positive patients;
3) Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks before enrollment;
4) Patients with severe liver and kidney insufficiency or heart insufficiency;
5) have multiple factors that affect oral drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea, and intestinal obstruction);

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
Paclitaxel for injection (albumin-bound)100 mg/m2, day 1, day 8, every 21 days for a cycle.	Drug	Single arm
AdebrelimabAlso: SHR-131620mg/kg or 1200mg, the first day, every 21 days as a cycle.	Drug	Single arm
Apatinib mesylate250mg once a day for 5 consecutive days and discontinue for 2 days	Drug	Single arm

Primary outcome

Objective response rate（ORR）
Time frame: 1 years
Refers to the proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to RECIST 1.1 criteria.

6 secondary outcomes

Disease control rate（DCR）
Time frame: 1 years
Progression-free survival (PFS)
Time frame: 1 years
Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR)
Time frame: 1 years
Overall survival（OS）
Time frame: 2 years
Occurence of AE and SAE
Time frame: 2 years
Appraisal of life quality
Time frame: 1 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 29 May 2024.
Individual participant dataSharing planned: No

Related trials for Gastric/Gastroesophageal Junction Adenocarcinoma

RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 2
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Stomach Neoplasms
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma

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.

Mingquan Cai contact

13696908231

mingquan035@163.com

Mingquan Cai principal investigator

The First Affiliated Hospital of Xiamen University

Xia Lv principal investigator

Xiamen Humanity Hospital

Jun Qiu principal investigator

Xiamen Humanity Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 18 inclusion and 33 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 29 May 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?

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 Mingquan Cai (13696908231, mingquan035@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate（ORR） (time frame: 1 years). 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 NCT06415669.

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 29 May 2024.