Gastric CancerICTCPTLAGCNCT05385900
Immune Combined Targeted and Chemotherapy in Perioperative Treatment of Locally Advanced Gastric Cancer
A study testing Penpulimab combination with anlotinib and chemotherapy in people with Gastric Cancer, run by Xijing Hospital.
Trial summary
An exploratory study of pembrolizumab combined with anlotinib and chemotherapy in the perioperative treatment of locally advanced gastric cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Penpulimab combination with anlotinib and chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2022to 30 Jun 2024
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age ≤ 70 years old, male or female;
- ECOG score 0~1 points;
- Patients with locally advanced gastric cancer (according to WHO 2015 classification) confirmed by pathology (histology or cytology);
- According to the eighth edition of clinical tumor TNM staging, patients with T3~4N+M0 gastric cancer confirmed by endoscopic ultrasonography and enhanced CT examination as resectable or potentially resectable;
- With measurable lesions (according to RECIST 1.1 criteria, the long diameter of CT scan of tumor lesions is ≥10mm, and the short diameter of CT scan of lymph node lesions is ≥15mm;), tumor diameter > 2cm;
- Those who were diagnosed with gastric cancer for the first time before enrolling in the group and who have not undergone radiotherapy, chemotherapy, surgery and targeted therapy;
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- Major organ function is normal, that is, the following criteria are met:
- Routine blood tests must meet (no blood transfusion, no hematopoietic factor and no drug correction within 14 days):
- ANC ≥ 1.5×109/L；
- PLT ≥ 100×109/L；
- HB ≥ 90 g/L；
- Biochemical tests must meet the following criteria:
- TBIL≤1.5×ULN；
- ALT、AST≤ 2.5×ULN
- serum creatinines Cr≤1.5×ULN，endogenous creatinine clearance≥50 mL/min（Cockcroft-Gault formula）；
- Coagulation function must meet the following criteria：INR≤1.5×ULN;APTT≤1.5×ULN； Patients with myocardial ischemia or myocardial infarction above grade 1, arrhythmia (including QTc≥450ms (male), QTc≥470ms (female)) and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification);
- Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days before starting the study drug, and be willing to use a medically-approved high-efficiency contraceptive during the study and within 3 months after the last dose of study drug ( Such as: intrauterine device, contraceptive pill or condom); for male subjects whose partner is a female of childbearing age, surgical sterilization, or agree to use an effective method during the study and within 3 months after the last study dose contraception;
- The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up;
Who cannot join
- Target disease exclusion criteria
- Patients with distant metastasis;
- Subjects who have previously received anti-PD-1 (L1) or CTLA4 monoclonal antibody therapy;
- Medical history and comorbidities
- Suffering from other malignant tumors in the past 3 years;
- Suffering from any active autoimmune disease or history of autoimmune disease (as follows, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, Hypothyroidism (may be included after hormone replacement therapy); patients with vitiligo or complete remission of childhood asthma who do not require any intervention in adulthood may be included; patients requiring medical intervention with bronchodilators are not included;
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- The use of immunosuppressive drugs within 14 days before the first use of the study drug, excluding nasal and inhaled corticosteroids or systemic steroids at physiological doses (ie, no more than 10 mg/day prednisone or its equivalent) );
- Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite optimal medical therapy);
- Patients with newly diagnosed angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; arrhythmia (including QTcF: ≥450 ms for males, ≥470 ms for females) requires long-term use of antiarrhythmic drugs and New York Cardiac Association classification ≥ class II cardiac insufficiency; or uncontrolled heart failure;
- There is evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, and severely impaired lung function;
- Complicated severe infection within 4 weeks before the first dose (eg: need for intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever >38.5°C during the screening period/before the first dose;
- Clinically significant hemoptysis (more than 50 mL of hemoptysis per day) within 3 months before the study, or clinically significant bleeding symptoms or obvious bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic Gastric ulcer, fecal occult blood++ or above baseline, or suffering from vasculitis, etc.).
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Administer live attenuated vaccines within 4 weeks before the first dose or during the study period;
- Physical examination and laboratory findings
- Patients with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (positive hepatitis C antibody, and high HCV-RNA) (the lower limit of detection of the analytical method) or co-infection with hepatitis B and C;
- Pregnant or breastfeeding women; patients with childbearing potential who are unwilling or unable to take effective contraceptive measures;
- Known positive history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
- Allergies, anaphylaxis and adverse drug reactions
- Severe allergic reactions to other monoclonal antibodies;
- Allergy or intolerance to infusion;
- Have a history of severe allergy to Anlotinib or its preventive medicines;
- Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or 5 half-lives of the research drug;
- The subject is known to have a history of psychotropic substance abuse, alcohol or drug abuse;
- The investigator believes that there are any conditions that may harm the subject or prevent the subject from meeting or performing the research requirements.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Exploratory Study of Pembrolizumab Combined With Anlotinib and Chemotherapy Neoadjuvant Therapy of Locally Advanced Gastric Cancer
An exploratory study of pembrolizumab combined with anlotinib and chemotherapy in the perioperative treatment of locally advanced gastric cancer
Read the detailed description
Previous studies have shown that anti-vascular drugs have excellent anti-tumor effects in the neoadjuvant treatment of locally advanced gastric cancer. The purpose of this study was to evaluate the neoadjuvant treatment of locally advanced gastric cancer with Penpulimab combined with anlotinib and chemotherapy. pathological complete response rate, disease-free survival, objective response rate, R0 resection rate and safety. The subjects used in the study were patients with resectable or potentially resectable T3~4N+M0 gastric cancer who were confirmed by endoscopic ultrasonography and enhanced CT. The specific dosing schedule of Piamprimab combined with anlotinib and chemotherapy was adopted. After receiving the corresponding neoadjuvant therapy for 3 cycles, surgery should be performed within 3-6 weeks after drug withdrawal; it is recommended that patients be given corresponding Adjuvant therapy, the specific adjuvant therapy plan shall be formulated by the investigator according to the individual situation of the patient. The primary endpoint was pathological complete response rate, and secondary key indicators were disease-free survival, objective response rate, R0 resection rate, and safety.
- Conditions
- Gastric Cancer
- Being tested
- Penpulimab combination with anlotinib and 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.
Penpulimab combination with anlotinib and chemotherapyDrug
Also called Teggio, Oxaliplatin
Penpulimab: fixed dose of 200 mg, administered on day 1 of each cycle, repeated every 3 weeks; Anlotinib: 12 mg, administered on days 1-14 of each cycle, orally once a day, about half an hour before breakfast (the time of daily administration should be the same as possible), with warm water, every 3 weeks Repeat 1 time
| Study group | Role | What they receive |
|---|---|---|
| Penpulimab in combination with anlotinib and chemotherapy | Experimental | After receiving the corresponding neoadjuvant therapy for 3 cycles according to the established treatment plan, surgery should be performed within 3-6 weeks after drug withdrawal. Receives: Drug: Penpulimab combination with anlotinib and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response, pCR
Defined as tumor tissue specimens resected surgically after neoadjuvant therapy with no residual tumor cells.
Measured: 12months
Secondary outcomes (1)
major pathologic response, MPR
Defined as tumor specimens resected after neoadjuvant therapy with residual tumor cells ≤10%
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start30 Jun 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2024 (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 Xijing 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Penpulimab in combination with anlotinib and chemotherapy
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liu Hong, Study chair, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385900
- Sponsor's protocol ID
- TQXB-GC-II-002
- Acronym
- ICTCPTLAGC
- Status last verified
- Mar 2022
- First submitted
- 17 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Pembrolizumab Combined With Anlotinib and Chemotherapy Neoadjuvant Therapy of Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT05385900
- Acronym / sponsor ID
- ICTCPTLAGC / TQXB-GC-II-002
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 23 May 2022 (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.
An exploratory study of pembrolizumab combined with anlotinib and chemotherapy in the perioperative treatment of locally advanced gastric cancer
Detailed description
Previous studies have shown that anti-vascular drugs have excellent anti-tumor effects in the neoadjuvant treatment of locally advanced gastric cancer. The purpose of this study was to evaluate the neoadjuvant treatment of locally advanced gastric cancer with Penpulimab combined with anlotinib and chemotherapy. pathological complete response rate, disease-free survival, objective response rate, R0 resection rate and safety. The subjects used in the study were patients with resectable or potentially resectable T3~4N+M0 gastric cancer who were confirmed by endoscopic ultrasonography and enhanced CT. The specific dosing schedule of Piamprimab combined with anlotinib and chemotherapy was adopted. After receiving the corresponding neoadjuvant therapy for 3 cycles, surgery should be performed within 3-6 weeks after drug withdrawal; it is recommended that patients be given corresponding Adjuvant therapy, the specific adjuvant therapy plan shall be formulated by the investigator according to the individual situation of the patient. The primary endpoint was pathological complete response rate, and secondary key indicators were disease-free survival, objective response rate, R0 resection rate, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Penpulimab in combination with anlotinib and chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Penpulimab in combination with anlotinib and chemotherapy | Experimental | Drug: Penpulimab combination with anlotinib and chemotherapyAfter receiving the corresponding neoadjuvant therapy for 3 cycles according to the established treatment plan, surgery should be performed within 3-6 weeks after drug withdrawal. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 18 years old ≤ age ≤ 70 years old, male or female;
- ECOG score 0~1 points;
- Patients with locally advanced gastric cancer (according to WHO 2015 classification) confirmed by pathology (histology or cytology);
- According to the eighth edition of clinical tumor TNM staging, patients with T3~4N+M0 gastric cancer confirmed by endoscopic ultrasonography and enhanced CT examination as resectable or potentially resectable;
- With measurable lesions (according to RECIST 1.1 criteria, the long diameter of CT scan of tumor lesions is ≥10mm, and the short diameter of CT scan of lymph node lesions is ≥15mm;), tumor diameter > 2cm;
Key exclusion criteria (25 listed)
- Target disease exclusion criteria
- Medical history and comorbidities
- Physical examination and laboratory findings
- Allergies, anaphylaxis and adverse drug reactions
- Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or 5 half-lives of the research drug;
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 |
|---|---|---|
| Penpulimab combination with anlotinib and chemotherapyAlso: Teggio, OxaliplatinPenpulimab: fixed dose of 200 mg, administered on day 1 of each cycle, repeated every 3 weeks; Anlotinib: 12 mg, administered on days 1-14 of each cycle, orally once a day, about half an hour before breakfast (the time of daily administration should be the same as possible), with warm water, every 3 weeks Repeat 1 time | Drug | Penpulimab in combination with anlotinib and chemotherapy |
Primary outcome
Pathological complete response, pCR
Time frame: 12months
Defined as tumor tissue specimens resected surgically after neoadjuvant therapy with no residual tumor cells.
1 secondary outcome
major pathologic response, MPR
Time frame: 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
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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.
Liu Hong study chair
Air Force Military Medical University, China
Questions about this trial
What is this clinical trial studying?
A study testing Penpulimab combination with anlotinib and chemotherapy in people with Gastric Cancer, run by Xijing Hospital.
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 25 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 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Liu Hong (13709284513, hongliu1@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response, pCR (time frame: 12months). 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 23 May 2022.