Gastric CancerPhase 2NCT03939962
Camrelizumab Combined With FOLFOX Neoadjuvant Therapy for Resectable Gastric and Gastroesophageal Junctional Adenocarcinoma
A Phase 2 study testing SHR1210 combined with FOLFOX in people with Gastric Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of immume checkpoint inhibitor PD-1 SHR1210 combined with chemotherapy in neoadjuvant therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- SHR1210 combined with FOLFOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2019to 30 May 2024
- 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 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-73 years old; male or female
- confirmed gastric and gastroesophageal junction adenocarcinoma by Gastroscopic biopsy histopathological examination
- Imaging (CT/MRI) and ultrasound gastroscopy confirmed: cT ≥ T2 and / or regional lymph node positive (N +);
- ECOG score: 0~2 points;
- Expected survival period ≥ 12 weeks;
- A histological specimen can be provided for secondary testing;
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- The main organ function meets the following criteria within 7 days before treatment:
- Blood routine examination criteria (without blood transfusion within 14 days):
- Hemoglobin (HB) ≥ 90g / L; The absolute value of neutrophils (ANC) ≥ 1.5 × 109 / L; Platelet (PLT) ≥ 80 × 109 / L (2) Biochemical examinations must meet the following criteria: Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) Aspartate aminotransferase (AST) ≤ 2.5 ULN; serum creatinine (Cr) ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60ml / min; (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).
- Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating patients; men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.
- The patient volunteered to participate in the study and signed an informed consent form;
Who cannot join
- Exceeding or currently suffering from other malignant tumors within 5 years, except for cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (in situ carcinoma) And T1 (tumor infiltrating basement membrane)];
- Patients with a high risk of bleeding or fistula due to the apparent invasion of adjacent organs (aorta or trachea);
- Before starting treatment， subject administrated corticosteroids (day> 10 mg equivalent dose prednisone), or other immunosuppressive drugs for systemic treatment of a disease within 14 days . In the absence of active autoimmune disease, >10 mg of daily prednisone equivalent dose of inhaled or topical steroid and adrenal replacement steroid doses are permitted;
- Anyone who has received any anti-tumor treatment in the past;
- Significantly malnourished patients. Exclusion is performed if the patient is receiving intravenous fluids or is required to be hospitalized for continuous infusion therapy. Patients with good nutrition control ≥ 28 days can be enrolled before randomization;
- Participants who received live/attenuated vaccine within 30 days of the first treatment;
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- Unresolved toxicity due to any previous treatment above CTC AE4.0 Level 2, excluding neurotoxicity of ≤2 caused by hair loss and oxaliplatin;
- Allergic reactions and adverse drug reactions:
- a history of allergies to the ingredients of the study drug;
- contraindications to any study drug (fluorouracil or oxaliplatin) in the chemotherapy regimen.
- Patients with any severe and/or uncontrolled disease, including:
- patients with hypertension who are not well controlled by antihypertensive drug (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg);
- with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 480ms) and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification);
- Severe or uncontrolled disease or active infection (≥CTCAE grade 2 infection), which the investigator believes may increase the risk associated with study participation, study drug administration, or affect the subject's ability to receive study medication;
- Renal failure requires hemodialysis or peritoneal dialysis;
- a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
- Patients with diabetes who have poor glycemic control (fasting blood glucose (FBG) > 10 mmol/L); subjects with active, known or suspected autoimmune diseases. Subjects with type 1 diabetes, residual hypothyroidism caused by autoimmune thyroiditis requiring hormone replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) can be enrolled;
- patients with seizures and requiring treatment;
- The subject has an interstitial lung disease that is symptomatic or may interfere with the discovery or management of suspected drug-related lung toxicity; previous and current subjects with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severe impaired lung function, etc. that may interfere with the detection and management of suspected drug-related lung toxicity;
- Patients with gastrointestinal diseases such as intestinal obstruction (including incomplete intestinal obstruction) or those who may have caused gastrointestinal bleeding, perforation or obstruction;
- Patients who underwent surgical treatment, incisional biopsy or significant traumatic injury within 28 days prior to enrollment;
- In the 4 weeks prior to enrollment, patients with any bleeding event ≥ CTCAE 3 have unhealed wounds, ulcers or fractures;
- Overactive/venous thrombosis events within 3 months, such as cerebrovascular accidents (including transient ischemic attacks), deep static Pulmonary thrombosis and pulmonary embolism;
- Prepare or accept previous allogeneic or allogeneic bone marrow transplantation, including liver transplantation;
- According to the investigator's judgment, there is a concomitant disease that seriously harms the patient's safety or affects the patient's completion of the study;
- Cannot perform biopsy to provide histological specimens;
- those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder; Prepare or accept previous allogeneic or allogeneic bone marrow transplants, including liver transplants;
- Urine routine showed urinary protein ≥ 2+ and confirmed 24-hour urine protein quantitation > 1.0 g;
- Patients with brain metastases;
- Patients who have participated in other clinical trials of anti-tumor drugs within four weeks.
Trial locations and contacts
1 site in 1 country.
China1 site
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, 450008
About this study
Official title: Phase Ⅱ Study of PD-1 Inhibitor Combined With FOLFOX Neoadjuvant Therapy for Resectable Gastric and Gastroesophageal Junctional Adenocarcinoma
The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of immume checkpoint inhibitor PD-1 SHR1210 combined with chemotherapy in neoadjuvant therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma. In addition ，the investigators will explore the relationship between the immunophenotype of gastric cancer and the efficacy and drug resistance of immunotherapy combined with chemotherapy, and screen out biomarkers that can predict the efficacy of immunotherapy.
Read the detailed description
Neoadjuvant chemotherapy and neoadjuvant radiotherapy and chemotherapy can not only improve the surgical resection rate and postoperative pathological remission rate, but also prolong the postoperative recurrence-free survival and benefit patients.Recent studies have confirmed that immume point inhibitors PD-1 and CTLA-4 monoclonal antibody have a certain effect in advanced gastric and gastroesophageal junction adenocarcinoma which had experienced multi-line treatment. Furthermore，the FOLFOX protocol is recommended as a new adjuvant treatment for locally advanced gastric cancer.In order to further improve the surgical resection rate and survival rate by improving the efficacy of neoadjuvant therapy for locally advanced gastric and gastroesophageal junction adenocarcinoma, the investigators selected PD-1 monoclonal antibody combined with FOLFOX neoadjuvant therapy for locally advanced gastric and gastroesophageal junctions Adenocarcinoma.The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of immume checkpoint inhibitor PD-1 SHR1210 combined with chemotherapy in neoadjuvant therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma. In addition ，the investigators will explore the relationship between the immunophenotype of gastric cancer and the efficacy and drug resistance of immunotherapy combined with chemotherapy, and screen out biomarkers that can predict the efficacy of immunotherapy.
- Conditions
- Gastric Cancer
- Being tested
- SHR1210 combined with FOLFOX
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR1210 combined with FOLFOXDrug
- SHR1210, iv, 200 mg d1, 30-minute intravenous infusion, repeated every 14 days.
- FOLFOX: Oxaliplatin 85mg/m2 ivgtt 2h d1; 5-fluorouracil 400mg/m2 iv d1; leucovorin 400mg/m2 ivgtt 2h d1,5-fluorouracil 2400mg/m2 CIV 46h, repeated every 14 days Patients who have no disease progression and can tolerate surgery receive surgery. When the investigator believes that the patient is not suitable for continued medication or according to the RECIST 1.1 standard, the evaluation is PD and the medication is over. The PD-1 monoclonal antibody does not allow for reductions and can only delay or suspend medication.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Neoadjuvant therapy:SHR1210 combined with FOLFOX repeat every 14 days for a total of 4 cycles.
Adjuvant therapy:SHR1210 combined with chemotherapy (the specific regimen will be chosen at the discretion of the investigator), every 14 days for a total of 4 cycles. After that, the patients will receive camrelizumab monotherapy for up to 1 year (from the first SHR1210 treatment). Receives: Drug: SHR1210 combined with FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
The percentage of patients who have no residual cancer cells (gross or microscopically) at the resection margins.
Measured: Up to approximately 16 weeks
pathological complete response (pCR) rate
The percentage of patients with no residual cancer cells at the primary cancer site and N(-) per histological evaluation.
Measured: Up to approximately 16 weeks
Secondary outcomes (5)
Near pathological complete response (near-pCR) rate
Near-pCR rate is defined as the percentage of patients with grade 0-1 tumors per NCCN tumor regression grading (TRG).
Measured: Up to approximately 16 weeks
Overall survival(OS)
OS is defined as the time from the first dose to all-cause death.
Measured: From randomization to the date of death (up to approximately 4 years)
Progression-free survival(PFS)
PFS is defined as the time from the first dose to objective disease progression or death.
Measured: up to 2 years
Disease-free survival (DFS)
DFS is defined as the time from the postoperative baseline imaging evaluation to disease recurrence or death in subjects who are disease-free after surgery.
Measured: From randomization to the date of recurrence or death (up to approximately 4 years)
Percentage of Participants Who Experience One or More Adverse Events (AEs)
The incidence and grade of adverse events (including serious adverse events and immune-related adverse events) will be determined per NCI-CTCAE 4.0.
Measured: up to approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start24 Jul 2019
- Primary completion30 May 2021
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ying Liu, Principal investigator, Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939962
- Sponsor's protocol ID
- HNGC-004
- Status last verified
- May 2021
- First submitted
- 4 May 2019
- Last updated
- 26 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao Y, Li D, Zhuang J, Li Z, Xia Q, Li Z, Yu J, Wang J, Zhang Y, Li K, Xu S, Li S, Ma P, Cao Y, Liu C, Xu C, Liu Z, Wei J, Zhang C, Qiao L, Gao X, Hou Z, Liu C, Zheng R, Wang D, Liu Y. Comprehensive multi-omics analysis of resectable locally advanced gastric cancer: Assessing response to neoadjuvant camrelizumab and chemotherapy in a single-center, open-label, single-arm phase II trial. Clin Transl Med. 2024 May;14(5):e1674. doi: 10.1002/ctm2.1674.
PubMed 38685486
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Study of PD-1 Inhibitor Combined With FOLFOX Neoadjuvant Therapy for Resectable Gastric and Gastroesophageal Junctional Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03939962
- Acronym / sponsor ID
- HNGC-004
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 7 May 2019 (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.
The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of immume checkpoint inhibitor PD-1 SHR1210 combined with chemotherapy in neoadjuvant therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma. In addition ，the investigators will explore the relationship between the immunophenotype of gastric cancer and the efficacy and drug resistance of immunotherapy combined with chemotherapy, and screen out biomarkers that can predict the efficacy of immunotherapy.
Detailed description
Neoadjuvant chemotherapy and neoadjuvant radiotherapy and chemotherapy can not only improve the surgical resection rate and postoperative pathological remission rate, but also prolong the postoperative recurrence-free survival and benefit patients.Recent studies have confirmed that immume point inhibitors PD-1 and CTLA-4 monoclonal antibody have a certain effect in advanced gastric and gastroesophageal junction adenocarcinoma which had experienced multi-line treatment. Furthermore，the FOLFOX protocol is recommended as a new adjuvant treatment for locally advanced gastric cancer.In order to further improve the surgical resection rate and survival rate by improving the efficacy of neoadjuvant therapy for locally advanced gastric and gastroesophageal junction adenocarcinoma, the investigators selected PD-1 monoclonal antibody combined with FOLFOX neoadjuvant therapy for locally advanced gastric and gastroesophageal junctions Adenocarcinoma.The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of immume checkpoint inhibitor PD-1 SHR1210 combined with chemotherapy in neoadjuvant therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma. In addition ，the investigators will explore the relationship between the immunophenotype of gastric cancer and the efficacy and drug resistance of immunotherapy combined with chemotherapy, and screen out biomarkers that can predict the efficacy of immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: SHR1210 combined with FOLFOXNeoadjuvant therapy:SHR1210 combined with FOLFOX repeat every 14 days for a total of 4 cycles. Adjuvant therapy:SHR1210 combined with chemotherapy (the specific regimen will be chosen at the discretion of the investigator), every 14 days for a total of 4 cycles. After that, the patients will receive camrelizumab monotherapy for up to 1 year (from the first SHR1210 treatment). |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18-73 years old; male or female
- confirmed gastric and gastroesophageal junction adenocarcinoma by Gastroscopic biopsy histopathological examination
- Imaging (CT/MRI) and ultrasound gastroscopy confirmed: cT ≥ T2 and / or regional lymph node positive (N +);
- ECOG score: 0~2 points;
- Expected survival period ≥ 12 weeks;
Key exclusion criteria (30 listed)
- Exceeding or currently suffering from other malignant tumors within 5 years, except for cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (in situ carcinoma) And T1 (tumor infiltrating basement membrane)];
- Patients with a high risk of bleeding or fistula due to the apparent invasion of adjacent organs (aorta or trachea);
- Before starting treatment， subject administrated corticosteroids (day> 10 mg equivalent dose prednisone), or other immunosuppressive drugs for systemic treatment of a disease within 14 days . In the absence of active autoimmune disease, >10 mg of daily prednisone equivalent dose of inhaled or topical steroid and adrenal replacement steroid doses are permitted;
- Anyone who has received any anti-tumor treatment in the past;
- Significantly malnourished patients. Exclusion is performed if the patient is receiving intravenous fluids or is required to be hospitalized for continuous infusion therapy. Patients with good nutrition control ≥ 28 days can be enrolled before randomization;
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 |
|---|---|---|
| SHR1210 combined with FOLFOX1. SHR1210, iv, 200 mg d1, 30-minute intravenous infusion, repeated every 14 days. 2. FOLFOX: Oxaliplatin 85mg/m2 ivgtt 2h d1; 5-fluorouracil 400mg/m2 iv d1; leucovorin 400mg/m2 ivgtt 2h d1,5-fluorouracil 2400mg/m2 CIV 46h, repeated every 14 days Patients who have no disease progression and can tolerate surgery receive surgery. When the investigator believes that the patient is not suitable for continued medication or according to the RECIST 1.1 standard, the evaluation is PD and the medication is over. The PD-1 monoclonal antibody does not allow for reductions and can only delay or suspend medication. | Drug | treatment group |
Primary outcome
R0 resection rate
Time frame: Up to approximately 16 weeks
The percentage of patients who have no residual cancer cells (gross or microscopically) at the resection margins.
pathological complete response (pCR) rate
Time frame: Up to approximately 16 weeks
The percentage of patients with no residual cancer cells at the primary cancer site and N(-) per histological evaluation.
5 secondary outcomes
Near pathological complete response (near-pCR) rate
Time frame: Up to approximately 16 weeks
Overall survival(OS)
Time frame: From randomization to the date of death (up to approximately 4 years)
Progression-free survival(PFS)
Time frame: up to 2 years
Disease-free survival (DFS)
Time frame: From randomization to the date of recurrence or death (up to approximately 4 years)
Percentage of Participants Who Experience One or More Adverse Events (AEs)
Time frame: up to approximately 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Derived from this study: PubMed 38685486Zhao Y, Li D, Zhuang J, Li Z, Xia Q, Li Z, Yu J, Wang J, Zhang Y, Li K, Xu S, Li S, Ma P, Cao Y, Liu C, Xu C, Liu Z, Wei J, Zhang C, Qiao L, Gao X, Hou Z, Liu C, Zheng R, Wang D, Liu Y. Comprehensive multi-omics analysis of resectable locally advanced gastric cancer: Assessing response to neoadjuvant camrelizumab and chemotherapy in a single-center, open-label, single-arm phase II trial. Clin Transl Med. 2024 May;14(5):e1674. doi: 10.1002/ctm2.1674.
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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.
Ying Liu principal investigator
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
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 SHR1210 combined with FOLFOX in people with Gastric Cancer, run by Henan Cancer 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 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: Up to approximately 16 weeks). The study lists 2 primary outcomes in all. 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 NCT03939962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.