Locally Advanced Gastric CancerPhase 2CCWSA/OAFLAGNCT04792515
Camrelizumab Combined With SOX and/or Apatinib for Locally Advanced Gastric Cancer
A Phase 2 study testing Camrelizumab combined with SOX/ or apatinib in people with Locally Advanced Gastric Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This study was designed to evaluate the efficacy and safety of camrelizumab in combination with SOX and/or apatinib in the treatment of locally advanced gastric cancer or gastroesophageal junction adenocarcinoma.The primary endpoint was pathologic complete response (PCR).In addition, secondary efficacy endpoints… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Gastric Cancer
- What is being tested?
- Camrelizumab combined with SOX/ or apatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign written informed consent before screening;
- Male or female, ≥18 years old;
- Have at least one measurable lesion according to RECIST1.1;
- ECOG physical status score 0~1;
- Pathologically confirmed local progression (CT3/CT4N+M0) of gastric cancer or adenocarcinoma of the gastroesophageal junction without any previous treatment (Siewert II or III).
- According to the clinical staging standard, surgical treatment is planned after neoadjuvant chemotherapy.
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- Expected survival of more than 3 months;
- The main organs function normally, following criteria:
- Blood routine (no blood transfusion, no use of granulocyte colony stimulating factor (G-CSF) or other hematopoietic stimulating factor correction within 14 days before screening examination) : neutrophils ≥1.5× 109 /L, platelets ≥100×109/L, hemoglobin ≥90g/L;White blood cells acuity 3.5 x l09 / L II. Liver function: ALT and AST, ALT and AST ≤ 2.5×ULN; Total bilirubin (TBil) ≤ 1.5×ULN (Gilbert syndrome patients, ≤ 3×ULN); III. Renal function: serum creatinine (CR) ≤ 1.5×ULN or creatinine clearance (CCR) ≥60mL/ min; IV. Coagulation function: APTT, INR, PT ≤ 1.5×ULN;
Who cannot join
- Gastric squamous cell carcinoma, adenosquamous cell carcinoma, small cell carcinoma and undifferentiated gastric carcinoma confirmed by pathology;
- Positive HER-2 test (IHC3+ or IHC2+ amplified by FISH);
- Any previous anti-tumor therapy (including chemotherapy, radiotherapy, hormone therapy, and molecular targeted therapy);
- Cardiac and pyloric obstruction affects the patient's eating and gastric emptyor and has difficulties to swallow tablets;
- Previous immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, anti CD137 or anti CTLA-4 antibodies or any other antibodies or drugs that target co-stimulation of T cells or immune checkpoint pathways;
- Has developed or is currently having other malignant tumors within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, or other tumors/cancers that have undergone radical treatment and have been free of disease for at least 5 years;
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- Perimeter neuropathy is grade 2 or greater according to the common adverse event terminology (NCI-CTCAE V5.0);
- with known active central nervous system metastases (CNS) and/or cancerous meningitis;
- Any component of a product or preparation similar to the study drug PD-1 monoclonal antibody has ever caused a severe allergic reaction, including known severe allergic reaction to other monoclonal antibodies, oxaliplatin, S-1 and other related compounds (NCI-CTCAE V5.0≥3);
- a known history of hereditary bleeding or a blood clotting disorder that is at risk of bleeding;
- Patients who underwent major surgery within 4 weeks;
- Subjects who did not recover from complications from previous surgery, i.e., did not drop to ≤1 (CTCAE version 5.0) (excluding hair loss and fatigue);
- Immunosuppressive drugs should be used for 2 weeks or within 2 weeks or during the study, excluding the following situations:
- Intranasal, inhaled, topical or topical steroid injections (e.g. intraarticular); B) Systemic corticosteroids at physiological dose (≤10mg/day prednisone or equivalent); C) short-term (≤7 days) use of steroids to prevent or treat non-autoimmune allergic diseases;
- Subjects with active or preexisting autoimmune diseases that are likely to recur;
- Subjects with a known history of idiopathic pulmonary fibrosis, drug-induced pneumonia, histological pneumonia, or non-infectious pneumonia;
- known active tuberculosis history;
- A history of human immunodeficiency virus infection (HIV positive), other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, or stem cell transplantation;
- The hepatitis B or C virology test meets any of the following criteria at the time of screening:
- HBsAg positive, and the titer of HBV-DNA in peripheral blood ≥104 copy number /mL or ≥2000IU/mL (HBV carriers should be treated with antiviral therapy by the researcher as appropriate); B) Active hepatitis C: HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method;
- Subjects had active or uncontrollable infections requiring systematic treatment within 2 weeks before randomization;
- have received live virus vaccine within 4 weeks;
- The presence of uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage or medical intervention;
- gastrointestinal perforation and/or fistula occurred within 6 months, and gastrointestinal bleeding of clinical significance occurred within 3 months before randomization;
- have intestinal obstruction or the following diseases or history: inflammatory bowel disease or general bowel resection (partial colon resection or general small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea;
- with severe medical problems, such as level III and above abnormal cardiac function (NYHA), ischemic heart disease (such as myocardial infarction, or angina pectoris) such as cardiovascular disease, or a history of myocardial infarction , within 3 months after the drug of poorly controlled diabetes (FPG)≥10mmol/L) or poorly controlled hypertension, systolic blood pressure≥160mmHg and/or diastolic blood pressure≥100mmHg;
- Subjects who are lactating or who plan to become pregnant during treatment and within 6 months after treatment;
- subjects who are unwilling to receive effective contraceptives during treatment and within 6 months after treatment (including male subjects who are capable of making a woman pregnant and female subjects and their male partners);
- The investigator believes that subjects are not suitable for the study because of other conditions that may affect their compliance with the protocol and evaluation of the study indicators.
Trial locations and contacts
1 site in 1 country.
Peng Xia, PhD contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi
Chengxue Dang, PhD, 0086-13319202569, dangchengxue@mail.xjtu.edu.cn
About this study
Official title: A Single-arm, Multicenter Clinical Study of Evaluating Camrelizumab Combined With SOX and/or Apatinib in the Treatment of Locally Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
This study was designed to evaluate the efficacy and safety of camrelizumab in combination with SOX and/or apatinib in the treatment of locally advanced gastric cancer or gastroesophageal junction adenocarcinoma.The primary endpoint was pathologic complete response (PCR).In addition, secondary efficacy endpoints include R0 resection rate, objective response rate (ORR), and 1-year progression-free survival rate (PFSR) . They were set to demonstrate the therapeutic benefit of camrelizumab combined with SOX in patients 。
Read the detailed description
Screening period Subjects will enter the study screening period after signing the informed consent, and the maximum screening period will be 28 days. Those who meet all the inclusion criteria and do not meet the exclusion criteria will be allowed to enter the study treatment period.
Treatment period Patients received 2-4 cycles of neoadjuvant chemotherapy with camrelizumab +SOX regimen, and then received adjuvant chemotherapy with camrelizumab +SOX regimen after surgery, with a total of 8 cycles before and after surgery.
Camrelizumab: every 3 weeks (21 days) was given as one administration cycle. 200mg was given intravenously on the first day of each cycle. Dose adjustment is not allowed. Delayed administration is allowed.
Apatinib mesylate: 250mg, qd, stopped 28 days before surgery, and can be used by the investigator according to the patient's recovery 28 days after surgery.
Chemotherapy: The SOX regimen consisted of one cycle every 3 weeks (21 days).Dose adjustment is allowed. Delayed administration is allowed.
Oxaliplatin (OXA) : 130mg/m2, intravenous infusion, d1, infusion more than 2 hours.
Tigio Capsules (S-1) : Take orally after breakfast and dinner, twice daily, d1-14.
The dosing time window is ±3 days, but within 72 hours before each dosing, subjects must complete an examination that includes all clinical requirements to assess tolerance for continued dosing.
Subjects will continue to receive study therapy until disease progression (PD) occurs, intolerable toxicity occurs, a new antitumor therapy is initiated, treatment is terminated after careful consideration by the patient or investigator, or they die, or are lost to follow-up.
Clinical tumor evaluation during the screening period and throughout the study period will be based on RECIST version 1.1.Baseline tumor assessment was performed 28 days prior to the start of treatment.Enhanced computed tomography (CT) or magnetic resonance imaging (MRI) is recommended for tumor evaluation.Tumor efficacy evaluation was conducted every 2 cycles (±3 days) from the beginning of the first dose study until the occurrence of PD. The visit time for efficacy evaluation was fixed, regardless of whether the treatment cycle delay occurred.If treatment is discontinued for reasons other than PD, subjects will continue to undergo tumor evaluation until PD occurs, initiation of new antitumor therapy, withdrawal of informed consent, death, or loss of follow-up, whichever occurs first.In the event of clinical symptoms suggestive of PD, imaging methods should be used for subsequent evaluation in order to record and confirm tumor efficacy.
From the beginning of the first dose study treatment, a systematic safety assessment was carried out for each administration cycle.During the study treatment, a basic safety assessment was performed before each administration cycle, including completion of a physical examination, vital signs, and basic laboratory tests (ECG, blood routine, urine routine, fecal occult blood, blood biochemistry, coagulation function, etc.).
- Conditions
- Locally Advanced Gastric Cancer
- Being tested
- Camrelizumab combined with SOX/ or apatinib
- Keywords
- Camrelizumab ,Efficacy ,Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab combined with SOX/ or apatinibDrug
Camrelizumab: every 3 weeks (21 days) was given as one administration cycle. 200mg was given intravenously on the first day of each cycle. Dose adjustment is not allowed. Delayed administration is allowed.
Apatinib mesylate: 250mg, qd, stopped 28 days before surgery, and can be used by the investigator according to the patient's recovery 28 days after surgery.
Chemotherapy: The SOX regimen consisted of one cycle every 3 weeks (21 days).Dose adjustment is allowed. Delayed administration is allowed.
Oxaliplatin (OXA) : 130mg/m2, intravenous infusion, d1, infusion more than 2 hours.
Tigio Capsules (S-1) : Take orally after breakfast and dinner, twice daily, d1-14.
The dosing time window is ±3 days, but within 72 hours before each dosing, subjects must complete an examination that includes all clinical requirements to assess tolerance for continued dosing.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Patients were treated with camrelizumab combined with SOX/ or apatinib Receives: Drug: Camrelizumab combined with SOX/ or apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response (PCR)
The enhancement lesions disappeared completely
Measured: 6month
Secondary outcomes (3)
R0 resection rate
R0 resection rate
Measured: 6month
ORR
Objective response rate
Measured: 12month
Percentage of Progression-free survival (1-PFSR)
Percentage of Progression-free survival of 1 year
Measured: 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- 67 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Chengxue Dang, PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792515
- Sponsor's protocol ID
- XJTU1AFCT-2021-003
- Acronym
- CCWSA/OAFLAG
- Status last verified
- Jan 2021
- First submitted
- 7 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter Clinical Study of Evaluating Camrelizumab Combined With SOX and/or Apatinib in the Treatment of Locally Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04792515
- Acronym / sponsor ID
- CCWSA/OAFLAG / XJTU1AFCT-2021-003
- Conditions
- Locally Advanced Gastric Cancer
- Keywords
- Camrelizumab ,Efficacy ,Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to evaluate the efficacy and safety of camrelizumab in combination with SOX and/or apatinib in the treatment of locally advanced gastric cancer or gastroesophageal junction adenocarcinoma.The primary endpoint was pathologic complete response (PCR).In addition, secondary efficacy endpoints include R0 resection rate, objective response rate (ORR), and 1-year progression-free survival rate (PFSR) . They were set to demonstrate the therapeutic benefit of camrelizumab combined with SOX in patients 。
Detailed description
Screening period Subjects will enter the study screening period after signing the informed consent, and the maximum screening period will be 28 days. Those who meet all the inclusion criteria and do not meet the exclusion criteria will be allowed to enter the study treatment period.
Treatment period Patients received 2-4 cycles of neoadjuvant chemotherapy with camrelizumab +SOX regimen, and then received adjuvant chemotherapy with camrelizumab +SOX regimen after surgery, with a total of 8 cycles before and after surgery.
Camrelizumab: every 3 weeks (21 days) was given as one administration cycle. 200mg was given intravenously on the first day of each cycle. Dose adjustment is not allowed. Delayed administration is allowed.
Apatinib mesylate: 250mg, qd, stopped 28 days before surgery, and can be used by the investigator according to the patient's recovery 28 days after surgery.
Chemotherapy: The SOX regimen consisted of one cycle every 3 weeks (21 days).Dose adjustment is allowed. Delayed administration is allowed.
Oxaliplatin (OXA) : 130mg/m2, intravenous infusion, d1, infusion more than 2 hours.
Tigio Capsules (S-1) : Take orally after breakfast and dinner, twice daily, d1-14.
The dosing time window is ±3 days, but within 72 hours before each dosing, subjects must complete an examination that includes all clinical requirements to assess tolerance for continued dosing.
Subjects will continue to receive study therapy until disease progression (PD) occurs, intolerable toxicity occurs, a new antitumor therapy is initiated, treatment is terminated after careful consideration by the patient or investigator, or they die, or are lost to follow-up.
Clinical tumor evaluation during the screening period and throughout the study period will be based on RECIST version 1.1.Baseline tumor assessment was performed 28 days prior to the start of treatment.Enhanced computed tomography (CT) or magnetic resonance imaging (MRI) is recommended for tumor evaluation.Tumor efficacy evaluation was conducted every 2 cycles (±3 days) from the beginning of the first dose study until the occurrence of PD. The visit time for efficacy evaluation was fixed, regardless of whether the treatment cycle delay occurred.If treatment is discontinued for reasons other than PD, subjects will continue to undergo tumor evaluation until PD occurs, initiation of new antitumor therapy, withdrawal of informed consent, death, or loss of follow-up, whichever occurs first.In the event of clinical symptoms suggestive of PD, imaging methods should be used for subsequent evaluation in order to record and confirm tumor efficacy.
From the beginning of the first dose study treatment, a systematic safety assessment was carried out for each administration cycle.During the study treatment, a basic safety assessment was performed before each administration cycle, including completion of a physical examination, vital signs, and basic laboratory tests (ECG, blood routine, urine routine, fecal occult blood, blood biochemistry, coagulation function, etc.).
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: Camrelizumab combined with SOX/ or apatinibPatients were treated with camrelizumab combined with SOX/ or apatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily sign written informed consent before screening;
- Male or female, ≥18 years old;
- Have at least one measurable lesion according to RECIST1.1;
- ECOG physical status score 0~1;
- Pathologically confirmed local progression (CT3/CT4N+M0) of gastric cancer or adenocarcinoma of the gastroesophageal junction without any previous treatment (Siewert II or III).
Key exclusion criteria (29 listed)
- Gastric squamous cell carcinoma, adenosquamous cell carcinoma, small cell carcinoma and undifferentiated gastric carcinoma confirmed by pathology;
- Positive HER-2 test (IHC3+ or IHC2+ amplified by FISH);
- Any previous anti-tumor therapy (including chemotherapy, radiotherapy, hormone therapy, and molecular targeted therapy);
- Cardiac and pyloric obstruction affects the patient's eating and gastric emptyor and has difficulties to swallow tablets;
- Previous immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, anti CD137 or anti CTLA-4 antibodies or any other antibodies or drugs that target co-stimulation of T cells or immune checkpoint pathways;
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 |
|---|---|---|
| Camrelizumab combined with SOX/ or apatinibCamrelizumab: every 3 weeks (21 days) was given as one administration cycle. 200mg was given intravenously on the first day of each cycle. Dose adjustment is not allowed. Delayed administration is allowed. Apatinib mesylate: 250mg, qd, stopped 28 days before surgery, and can be used by the investigator according to the patient's recovery 28 days after surgery. Chemotherapy: The SOX regimen consisted of one cycle every 3 weeks (21 days).Dose adjustment is allowed. Delayed administration is allowed. Oxaliplatin (OXA) : 130mg/m2, intravenous infusion, d1, infusion more than 2 hours. Tigio Capsules (S-1) : Take orally after breakfast and dinner, twice daily, d1-14. The dosing time window is ±3 days, but within 72 hours before each dosing, subjects must complete an examination that includes all clinical requirements to assess tolerance for continued dosing. | Drug | treatment group |
Primary outcome
pathologic complete response (PCR)
Time frame: 6month
The enhancement lesions disappeared completely
3 secondary outcomes
R0 resection rate
Time frame: 6month
ORR
Time frame: 12month
Percentage of Progression-free survival (1-PFSR)
Time frame: 12month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- 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.
Peng Xia, PhD contact
Chengxue Dang, PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong 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 Camrelizumab combined with SOX/ or apatinib in people with Locally Advanced Gastric Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chengxue Dang, PhD (0086-13319202569, dangchengxue@mail.xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response (PCR) (time frame: 6month). 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 11 Mar 2021.