Gastric CancerNCT05800080
An Exploratory Study of Immunotherapy Combined With Anlotinib and Chemotherapy in Perioperative Treatment of LAGC
A study testing Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy in people with Gastric Cancer, run by Xijing Hospital at 1 site in China.
Trial summary
1. Main objective: to evaluate the pathological complete response (pCR) of gastric cancer after local advanced COVID-19 infection by two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and neoadjuvant chemotherapy. 2. 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 combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- Apr 2023to Feb 2025
- 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 confirmed by pathology (histology or cytology) (according to WHO classification in 2015);
- Nucleic acid test or antigen test to identify patients with COVID-19 infection
- According to the TNM stage of clinical tumor in the 8th edition, T3~4N+M0 gastric cancer patients confirmed as resectable or potentially resectable by endoscopic ultrasound and enhanced CT;
- It has measurable lesions (according to RECIST 1.1 standard, the long diameter of CT scan of tumor lesions is ≥ 10mm, and the short diameter of CT scan of lymph node lesions is ≥ 15mm;);
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- Those who were diagnosed as gastric cancer for the first time before enrollment and did not undergo radiotherapy, chemotherapy, surgery and targeted treatment;
- The function of main organs is normal, that is, they meet the following standards:
- The blood routine examination must meet the following requirements (no blood transfusion, no hemopoietic factor and no drug correction within 14 days):
- ANC ≥ 1.5 × 109/L；
- PLT ≥ 100 × 109/L；
- HB ≥ 90 g/L；
- Biochemical examination shall meet the following standards:
- TBIL≤1.5 × ULN；
- ALT、AST≤ 2.5 × ULN
- Serum creatinine sCr ≤ 1.5 × ULN, endogenous creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);
- Coagulation function must meet: INR ≤ 1.5 × ULN and APTT ≤ 1.5 × ULN；
- Female subjects of childbearing age must carry out a serum pregnancy test within 3 days before starting the study medication, and the result is negative, and are willing to use a medically approved effective contraceptive measure (such as intrauterine device, contraceptive or condom) during the study period and within 3 months after the last administration of the study medication; For male subjects whose partners are women of childbearing age, they should undergo surgical sterilization or agree to use effective methods of contraception during the study and within 3 months after the last study administration;
- Subjects voluntarily joined the study and signed the informed consent form, with good compliance and cooperation in follow-up;
Who cannot join
- Patients with distant metastasis;
- Subjects who have previously received anti-PD-1 (L1) or CTLA4 monoclonal antibodies;
- Medical history and complications
- Other malignant tumors in the past 3 years;
- Have any history of active autoimmune diseases or autoimmune diseases (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy); Patients with vitiligo or childhood asthma have been completely relieved and can be included without any intervention after adulthood; Patients who need bronchodilator for medical intervention cannot be included;
- Immunosuppressive drugs were used within 14 days before the first use of the study drug, excluding nasal spray and inhaled corticosteroids or systemic steroid hormones with physiological dose (i.e. no more than 10 mg/day prednisone or its equivalent);
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- Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, despite the best drug treatment);
- Newly diagnosed angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; Arrhythmias (including QTcF: male ≥ 450 ms, female ≥ 470 ms) require long-term use of antiarrhythmic drugs and cardiac insufficiency of New York Heart Association grade ≥ II; Or uncontrolled heart failure;
- There is evidence that there is pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia and serious damage to lung function in the past or at present;
- Severe infection (such as the need for intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever of unknown cause occurred during screening/before the first administration>38.5 ° C;
- There is clinically significant hemoptysis (more than 50 mL of hemoptysis per day) within the first three months of the study, or there is clinically obvious bleeding symptom or obvious bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood++or above the baseline, or suffering from vasculitis).
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Inoculate live attenuated vaccine within 4 weeks before the first administration or during the study period;
- Physical examination and laboratory examination findings
- People with congenital or acquired immune deficiency, such as people infected with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analytical method) or combined with hepatitis B and hepatitis C infection;
- Pregnant or lactating women; Those with fertility who are unwilling or unable to take effective contraceptive measures;
- Known to have a positive history of human immunodeficiency virus (HIV) test or known to have acquired immunodeficiency syndrome (AIDS);
- Allergic reactions, allergic reactions and adverse drug reactions
- Severe allergic reaction to other monoclonal antibodies;
- Allergy or intolerance to infusion;
- Have a history of severe allergy to arotinib or its preventive drugs;
- Subjects who are participating in other clinical studies or whose first medication is less than 4 weeks from the end of the previous clinical study (the last medication), or who have 5 half-lives of the study drug;
- Subjects are known to have a history of abuse of psychotropic substances, alcohol abuse or drug abuse;
- The researcher believes that there are any conditions that may damage the subject or cause the subject to fail to meet or perform the research requirements
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: An Exploratory Study of Immunotherapy Combined With Anlotinib Hydrochloride Capsules and Chemotherapy in Perioperative Treatment of Locally Advanced Novel Coronavirus Infected Gastric Cancer
- 1. Main objective: to evaluate the pathological complete response (pCR) of gastric cancer after local advanced COVID-19 infection by two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and neoadjuvant chemotherapy.
- 2. Secondary objective: to evaluate the major pathological response (MPR), disease-free survival (DFS), objective response rate (ORR), R0 resection rate (R0 resection rate) and safety of two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and neoadjuvant chemotherapy for gastric cancer after local advanced COVID-19 infection。
Read the detailed description
This is a prospective multicenter exploratory study to evaluate the efficacy and safety of two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and chemotherapy for resectable or potentially resectable T3~4N+M0 locally advanced gastric cancer after COVID-19 infection This study was led by Professor Hongliu, Department of Gastroenterology, Xijing Hospital. 114 patients with resectable or potentially resectable T3~4N+M0 locally advanced gastric cancer were planned to be randomly divided into two groups: one group received peri-operative treatment with Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy, and the other group received peri-operative treatment with Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy. Each subject will receive three cycles of neoadjuvant study treatment: Pianzumab (single immunity, fixed dose 200mg) or Cadonilimab (double immunity, fixed dose 500mg), which will be administered on the first day of each cycle and repeated every three weeks; Anlotinib Hydrochloride Capsules: 12mg, administered on the 1-14th day of each cycle, once a day, about half an hour before breakfast (the time of daily administration should be the same as much as possible), delivered with warm water, repeated once every 3 weeks; Tegafur: It needs to be administered according to the patient's body surface area< 40 mg/time at 1.25 m2; ≥ 50 mg/time when 1.25m2 and<1.5 m2; ≥ 60 mg/time at 1.5 m2; Take orally, twice a day, after breakfast and dinner, for 14 consecutive days, and rest for 7 days, which is a treatment cycle; Repeat once every 3 weeks; Oxaliplatin: 130 mg/m2, administered on the first day of each cycle, repeated every three weeks.
- Conditions
- Gastric Cancer
- Being tested
- Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules 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 combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapyDrug
Also called Teggio, Oxaliplatin
one group receives peri operative treatment of Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy, and the other group receives peri operative treatment of Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy.After receiving corresponding neoadjuvant treatment for 3 cycles according to the established treatment plan, surgical treatment shall be carried out within 3-6 weeks after drug withdrawal
| Study group | Role | What they receive |
|---|---|---|
| Single immunotherapy group； | Experimental | one group receives peri operative treatment of Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy； Receives: Drug: Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy |
| Double immune treatment group | Experimental | one group receives peri operative treatment of Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy Receives: Drug: Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pathological complete response;
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 posted5 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2025 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group receives peri operative treatment of Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy, and the other group receives peri operative treatment of Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy Penpulimab (single immunity, fixed dose 200mg) orCadonilimab (double immunity, fixed dose 500mg), which will be administered on the first day of each cycle and repeated every three weeks; Anlotinib Hydrochloride Capsules: 12mg, administered on the 1-14th day of each cycle Other Names: Teggio Oxaliplatin
- Masking
- None (open label)
- Enrolment
- 114 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
- NCT05800080
- Sponsor's protocol ID
- AK104-IIT-C-W-0031
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- 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 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Immunotherapy Combined With Anlotinib Hydrochloride Capsules and Chemotherapy in Perioperative Treatment of Locally Advanced Novel Coronavirus Infected Gastric Cancer
- ClinicalTrials.gov ID
- NCT05800080
- Acronym / sponsor ID
- AK104-IIT-C-W-0031
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 5 Apr 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.
- 1. Main objective: to evaluate the pathological complete response (pCR) of gastric cancer after local advanced COVID-19 infection by two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and neoadjuvant chemotherapy.
- 2. Secondary objective: to evaluate the major pathological response (MPR), disease-free survival (DFS), objective response rate (ORR), R0 resection rate (R0 resection rate) and safety of two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and neoadjuvant chemotherapy for gastric cancer after local advanced COVID-19 infection。
Detailed description
This is a prospective multicenter exploratory study to evaluate the efficacy and safety of two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and chemotherapy for resectable or potentially resectable T3~4N+M0 locally advanced gastric cancer after COVID-19 infection This study was led by Professor Hongliu, Department of Gastroenterology, Xijing Hospital. 114 patients with resectable or potentially resectable T3~4N+M0 locally advanced gastric cancer were planned to be randomly divided into two groups: one group received peri-operative treatment with Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy, and the other group received peri-operative treatment with Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy. Each subject will receive three cycles of neoadjuvant study treatment: Pianzumab (single immunity, fixed dose 200mg) or Cadonilimab (double immunity, fixed dose 500mg), which will be administered on the first day of each cycle and repeated every three weeks; Anlotinib Hydrochloride Capsules: 12mg, administered on the 1-14th day of each cycle, once a day, about half an hour before breakfast (the time of daily administration should be the same as much as possible), delivered with warm water, repeated once every 3 weeks; Tegafur: It needs to be administered according to the patient's body surface area< 40 mg/time at 1.25 m2; ≥ 50 mg/time when 1.25m2 and<1.5 m2; ≥ 60 mg/time at 1.5 m2; Take orally, twice a day, after breakfast and dinner, for 14 consecutive days, and rest for 7 days, which is a treatment cycle; Repeat once every 3 weeks; Oxaliplatin: 130 mg/m2, administered on the first day of each cycle, repeated every three weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- one group receives peri operative treatment of Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy, and the other group receives peri operative treatment of Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy Penpulimab (single immunity, fixed dose 200mg) orCadonilimab (double immunity, fixed dose 500mg), which will be administered on the first day of each cycle and repeated every three weeks; Anlotinib Hydrochloride Capsules: 12mg, administered on the 1-14th day of each cycle Other Names: Teggio Oxaliplatin
| Arm | Type | Receives |
|---|---|---|
| Single immunotherapy group； | Experimental | Drug: Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapyone group receives peri operative treatment of Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy； |
| Double immune treatment group | Experimental | Drug: Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapyone group receives peri operative treatment of Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 18 years old ≤ age ≤ 70 years old, male or female;
- ECOG score 0-1 points;
- Patients with locally advanced gastric cancer confirmed by pathology (histology or cytology) (according to WHO classification in 2015);
- Nucleic acid test or antigen test to identify patients with COVID-19 infection
- According to the TNM stage of clinical tumor in the 8th edition, T3~4N+M0 gastric cancer patients confirmed as resectable or potentially resectable by endoscopic ultrasound and enhanced CT;
Key exclusion criteria (24 listed)
- Patients with distant metastasis;
- Subjects who have previously received anti-PD-1 (L1) or CTLA4 monoclonal antibodies;
- Medical history and complications
- Other malignant tumors in the past 3 years;
- Have any history of active autoimmune diseases or autoimmune diseases (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy); Patients with vitiligo or childhood asthma have been completely relieved and can be included without any intervention after adulthood; Patients who need bronchodilator for medical intervention cannot be included;
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 combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapyAlso: Teggio, Oxaliplatinone group receives peri operative treatment of Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy, and the other group receives peri operative treatment of Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy.After receiving corresponding neoadjuvant treatment for 3 cycles according to the established treatment plan, surgical treatment shall be carried out within 3-6 weeks after drug withdrawal | Drug | Double immune treatment group, Single immunotherapy group； |
Primary outcome
The pathological complete response;
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 5 Apr 2023.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy in people with Gastric Cancer, run by Xijing 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 19 inclusion and 24 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 5 Apr 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 Liu Hong (+86-13709284513, hongliu1@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pathological complete response; (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 5 Apr 2023.