Gastric CancerPhase 2NCT04367025
Efficacy and Safety of Perioperative Chemotherapy Plus PD-1 Antibody in Gastric Cancer
A Phase 2 study testing Camrelizumab, Oxaliplatin and S1 in people with Gastric Cancer, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
For locally advanced gastric cance, neoadjuvant chemotherapy can increase the resectability of tumor, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and… 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?
- Camrelizumab, Oxaliplatin and S1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- May 2020to May 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written (signed) informed consent.
- Age ≥ 18 years and ≤70 years.
- ECOG Performance status 0-1.
- Has previously untreated localized gastric or gastroesophageal junction adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease.
- Patients who plan surgery after neoadjuvant chemotherapy based on clinical staging criteria.
- Consent to send tumor tissue from biopsy or resection for PD-L1 detection and PD-L1 CPS≥1;
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- Expected survival ≥6 months;
- Females of child bearing age must have a negative pregnancy test
- 1）Platelet (PLT) ≥100×109/L; 2) Neutrophil count (ANC)≥1.5×l09/L; 3) Hemoglobin (Hb) level ≥9.0 g/dl; 4）WBC≥3.5×l09/L; 5) International normalized ratio (INR) ≤1.5; 5) Prothrombin time (PT) ,International Normalized Ratio（INR）and activated partial thromboplastin time (APTT) ≤1.5×ULN; 6）Total bilirubin (TBIL) level ≤1.5×ULN（patients with gilbert syndrome≤3×ULN）; 7) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level ≤2.5×ULN ; 10) Serum creatinine (Cr) level ≤1.5×ULN and creatinine clearance ≥60 ml/min;
Who cannot join
- Patients with pathologically confirmed gastric squamous cell carcinoma, adenosquamous carcinoma, small cell carcinoma, and undifferentiated gastric cancer.
- patients who have HER2 positive confiemed with IHC3+ or IHC2+ and FISH positive.
- Patients with a history of t Anticancer or Experimental Therapy(Including chemotherapy, radiotherapy, hormone therapy and molecular targeted therapy)
- The patient's cardia or pylorus is nearly obstructed, affecting eating and gastric emptying
- Immunotherapy with previous anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or any other antibody or drug that targets T-cell co-stimulation or immune checkpoint pathways
- Patients have experienced or currently has other malignancies within 5 years.Except for the cured cervical carcinoma in situ,Non-melanoma skin cancer, Other tumors or cancers that have been treated radically and have shown no signs of disease for at least 5 years.
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- Peripheral neuropathy ≥ level 2（according to CTCAE 5.0）
- Patient currently has CNS or cancerous meningitis.
- Patients are allergic to study medication and its ingredients
- Patients have hereditary bleeding or coagulopathy at risk of bleeding
- Patient underwent major surgery within 4 weeks
- Patients have taken Chinese herbal medicine or proprietary Chinese medicine for cancer treatment within two weeks
- Patients have not recovered from complications of previous surgery.According to the CTCAE 5.0, it has not been reduced below level 1(In addition to hair loss and fatigue)
- Patients require immunosuppressive drugs within 2 weeks or less or during the study.Exclude the following:
- Use of intranasal, inhaled or topical steroid(For example, intra - articular injection) B) physiological dose of steroid ( Prednisone less than 10mg per day or use equivalent dose) C) Short-term(no more than 7 day) use of steroids to prevent or treat non-autoimmune allergic diseases
- Patients have an active or history of autoimmune disease that may recur
- Patients have a history of interstitial lung disease or non-infectious pneumonia
- Patients have a history of active tuberculosis
- Patients have a history of HIV infection or other acquired, congenital immunodeficiency disease , organ transplant or stem cell transplant
- Hepatitis B or C virus virological tests meet any of the following:
- HBsAg positive ,HBV-DNA≥150 copies/mL or ≥2000IU/mL B) HCV antibody positive and HCV-RNA is above the detection limit of the analysis method
- Within 2 weeks or 2 weeks before randomization,Patients have an active or uncontrollable infection that requires systemic treatment
- Patient vaccinated with live virus within 4 weeks
- Patients have uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage or treatment.
- Patients have gastrointestinal perforation or fistula within 6 months and significant clinically significant gastrointestinal bleeding before 3 months of randomization
- Patient have intestinal obstruction, inflammatory bowel disease, extensive bowel resection, Crohn's disease, ulcerative colitis or chronic diarrhea
- Patients have serious internal medicine diseases
- Women who are pregnant, breast-feeding or planning to become pregnant during treatment or within 6 months after treatment ends.
- Patients are unwilling to receive effective contraception during treatment and within 6 months after treatment ends
- The investigator believes that the subject is not suitable for the study
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese PLA General Hospital
Beijing
Baoqing Jia, professor, +861066937523, baoqingjia@126.com
Baoqing Jia, professor
About this study
Official title: Efficacy and Safety of Perioperative Chemotherapy Plus PD-1 Antibody (Camrelizumabin) the Locally Advanced Adenocarcinoma of Stomach or Gastroesophageal Junction
For locally advanced gastric cance, neoadjuvant chemotherapy can increase the resectability of tumor, and finally improve the long-term survival.
Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Camrelizumab（SHR-1210） in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma and Hepatocellular carcinoma.
This study is a single center, open-label, randomized comparative phase II clinical trial to evaluate safety and efficacy of Camrelizumab in combination with perioperative chemotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction. Differences in T cell expression were detected by single cell RNA sequencing to screen people who were more sensitive to immunotherapy.
Read the detailed description
Gastric cancer is one of the most common malignancies in China with incidence and mortality both ranking the 2nd among malignancies in China. Surgery is the only possible way to cure gastric cancer, however, over 80-90% of gastric cancer patients in China are in advanced stage. Locally advanced gastric cancer could be cured by multi-disciplinary therapies including surgery, chemotherapy and radiotherapy. Neoadjuvant chemotherapy can increase the resectability of tumor, and finally improve the long-term survival. However, the therapeutic effects remain unsatisfactory.
Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Camrelizumab in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma and Hepatocellular carcinoma .This study is a single center, open-label, randomized comparative phase II clinical trial to evaluate safety and efficacy of Camrelizumab in combination with perioperative chemotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction. Differences in T cell expression were detected by single cell RNA sequencing to screen people who were more sensitive to immunotherapy.
- Conditions
- Gastric Cancer
- Being tested
- Camrelizumab, Oxaliplatin, S1
- Keywords
- Gastric cancer, Camrelizumab, neoadjuvant, 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.
CamrelizumabDrug
Also called SHR-1210
Camrelizumab: 200mg,iv drip for 1h,d1,q3w
OxaliplatinDrug
Also called OXA
Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w;
S1Drug
S-1:40~60mg Bid, d1~14, q3w;
| Study group | Role | What they receive |
|---|---|---|
| SOX | Active comparator | SOX: Oxaliplatin+S-1 Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w; S-1:40~60mg Bid, d1~14, q3w; Neoadjuvant chemotherapy for 2-4 cycles, adjuvant chemotherapy for 2-4 cycles Receives: Drug: Oxaliplatin; Drug: S1 |
| Camrelizumab+ SOX | Experimental | Camrelizumab:200mg,iv drip for 1h,d1,q3w SOX: Oxaliplatin+S-1 Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w; S-1:40~60mg Bid, d1~14, q3w; Neoadjuvant chemotherapy+ Camrelizumab for 2-4 cycles, adjuvant chemotherapy + Camrelizumab for 2-4 cycles. Receives: Drug: Camrelizumab; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic response (MPR)
It is defined as residual tumors less than 10% after neoadjuvant chemotherapy.
Measured: At time of surgery
Secondary outcomes (5)
Objective response rate(ORR)
It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR.
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
pCR
Pathological complete response
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks
Disease-free survival (DFS)
The time from the beginning of randomization to the recurrence of the disease or the death of the patient due to disease progression
Measured: 3years
Overall survival(OS)
The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date.
Measured: From the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first,assessed up to 3 years
OSR
overall survival rate
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study startMay 2020 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2023 (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 Chinese PLA General 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baoqing Jia, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367025
- Sponsor's protocol ID
- OBU-BJ-GC-II-007
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Perioperative Chemotherapy Plus PD-1 Antibody (Camrelizumabin) the Locally Advanced Adenocarcinoma of Stomach or Gastroesophageal Junction
- ClinicalTrials.gov ID
- NCT04367025
- Acronym / sponsor ID
- OBU-BJ-GC-II-007
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Camrelizumab, neoadjuvant, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 29 Apr 2020 (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.
For locally advanced gastric cance, neoadjuvant chemotherapy can increase the resectability of tumor, and finally improve the long-term survival.
Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Camrelizumab（SHR-1210） in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma and Hepatocellular carcinoma.
This study is a single center, open-label, randomized comparative phase II clinical trial to evaluate safety and efficacy of Camrelizumab in combination with perioperative chemotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction. Differences in T cell expression were detected by single cell RNA sequencing to screen people who were more sensitive to immunotherapy.
Detailed description
Gastric cancer is one of the most common malignancies in China with incidence and mortality both ranking the 2nd among malignancies in China. Surgery is the only possible way to cure gastric cancer, however, over 80-90% of gastric cancer patients in China are in advanced stage. Locally advanced gastric cancer could be cured by multi-disciplinary therapies including surgery, chemotherapy and radiotherapy. Neoadjuvant chemotherapy can increase the resectability of tumor, and finally improve the long-term survival. However, the therapeutic effects remain unsatisfactory.
Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Camrelizumab in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma and Hepatocellular carcinoma .This study is a single center, open-label, randomized comparative phase II clinical trial to evaluate safety and efficacy of Camrelizumab in combination with perioperative chemotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction. Differences in T cell expression were detected by single cell RNA sequencing to screen people who were more sensitive to immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOX | Active comparator | Drug: Oxaliplatin, Drug: S1SOX: Oxaliplatin+S-1 Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w; S-1:40~60mg Bid, d1~14, q3w; Neoadjuvant chemotherapy for 2-4 cycles, adjuvant chemotherapy for 2-4 cycles |
| Camrelizumab+ SOX | Experimental | Drug: Camrelizumab, Drug: OxaliplatinCamrelizumab:200mg,iv drip for 1h,d1,q3w SOX: Oxaliplatin+S-1 Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w; S-1:40~60mg Bid, d1~14, q3w; Neoadjuvant chemotherapy+ Camrelizumab for 2-4 cycles, adjuvant chemotherapy + Camrelizumab for 2-4 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written (signed) informed consent.
- Age ≥ 18 years and ≤70 years.
- ECOG Performance status 0-1.
- Has previously untreated localized gastric or gastroesophageal junction adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease.
- Patients who plan surgery after neoadjuvant chemotherapy based on clinical staging criteria.
Key exclusion criteria (30 listed)
- Patients with pathologically confirmed gastric squamous cell carcinoma, adenosquamous carcinoma, small cell carcinoma, and undifferentiated gastric cancer.
- patients who have HER2 positive confiemed with IHC3+ or IHC2+ and FISH positive.
- Patients with a history of t Anticancer or Experimental Therapy(Including chemotherapy, radiotherapy, hormone therapy and molecular targeted therapy)
- The patient's cardia or pylorus is nearly obstructed, affecting eating and gastric emptying
- Immunotherapy with previous anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or any other antibody or drug that targets T-cell co-stimulation 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 |
|---|---|---|
| CamrelizumabAlso: SHR-1210Camrelizumab: 200mg,iv drip for 1h,d1,q3w | Drug | Camrelizumab+ SOX |
| OxaliplatinAlso: OXAOxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w; | Drug | Camrelizumab+ SOX, SOX |
| S1S-1:40~60mg Bid, d1~14, q3w; | Drug | SOX |
Primary outcome
Major pathologic response (MPR)
Time frame: At time of surgery
It is defined as residual tumors less than 10% after neoadjuvant chemotherapy.
5 secondary outcomes
Objective response rate(ORR)
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
pCR
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks
Disease-free survival (DFS)
Time frame: 3years
Overall survival(OS)
Time frame: From the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first,assessed up to 3 years
OSR
Time frame: 3years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
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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.
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, Oxaliplatin and S1 in people with Gastric Cancer, run by Chinese PLA General 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 9 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 29 Apr 2020. 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 Baoqing Jia, professor (+861066937523, baoqingjia@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic response (MPR) (time frame: At time of surgery). 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 29 Apr 2020.