Locally Advanced Gastric CancerPhase 2NCT05545436
Carrelizumab (PD-1) Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Gastric Cancer
A Phase 2 study testing Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine ) in people with Locally Advanced Gastric Cancer, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This is a single-arm, open, exploratory clinical study to evaluate the efficacy of carrelizumab (PD-1) combined with chemotherapy (SOX/XELOX) as neoadjuvant therapy and to observe the changes of tumor immune microenvironment in patients with locally advanced gastric or gastroesophageal junction cancer (T3-4NXM0). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Gastric Cancer
- What is being tested?
- Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2022to Jun 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
- T3-4NxM0 locally advanced gastric or gastroesophageal junction carcinoma was confirmed by gastroscopic biopsy, CT and pathological examination;
- No previous systematic treatment for the current disease;
- Age ≥ 70 years, age ≥18 years, both sexes;
- ECOG physical status score 0-1; Full organ and bone marrow function:
- Blood routine: hemoglobin ≥90g/L, neutrophil count ≥1.5×10^9/L, platelet count ≥75×10^9/L; Liver function: serum total bilirubin ≤1.5× upper normal value (UNL), aspartate transferase ≤3×UNL, alanine Acid transferase ≤3×UNL; Renal function: serum creatinine ≤1.5×UNL, creatinine clearance rate ≥50ml/min; Coagulation function: INR, APTT and PT ≤1.5×UNL; Serum albumin ≥30g/L; Thyrotropin (TSH) and free thyroxine (fT4) were within the range of normal ±10%.
- Electrocardiogram showed no obvious abnormality.
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- Not receiving blood transfusion, blood products, or blood cell growth factors such as granulocyte colony-stimulating factor within 2 weeks;
- Sign an informed consent form before starting the study on a specific screening procedure;
- The estimated survival time is more than 3 months;
- Subjects volunteered to join this study, with good compliance, safety and survival follow-up -
Who cannot join
- Patients with any of the following were excluded from the study:
- People with allergic disease, history of severe drug allergy, known allergy to macromolecular protein preparations or carrelizumab;
- Early gastric cancer;
- Gastric cancer patients with HER2 amplification by pathological gene detection;
- History of other malignancies (except cured basal cell carcinoma of the skin, cured cervix) with disease-free survival <5 years Carcinoma in situ and gastrointestinal neoplasms proven to be cured by endoscopic mucosal resection);
- The presence or history of any active autoimmune disease (including but not limited to: interstitial pneumonia, Uveitis, enteritis, nephritis, hyperthyroidism, hypothyroidism);
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- You are using immunosuppressive agents or hormone therapy (systemic or topical) to achieve immunosuppression, and Continued to use within 2 weeks before enrollment;
- Severe infection (if intravenous antibiotics, antifungal or antiviral drugs are needed);
- Congenital or acquired immune deficiency (such as HIV-infected persons), or active hepatitis ((with regular antiviral treatment)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Hongbo Wei, M.D., Ph.D., 8613760660785
About this study
Official title: A Single-center Prospective Single-arm Study of the Efficacy of Carrelizumab (PD-1) Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Gastric Cancer and Its Effect on Tumor Immune Microenvironment
This is a single-arm, open, exploratory clinical study to evaluate the efficacy of carrelizumab (PD-1) combined with chemotherapy (SOX/XELOX) as neoadjuvant therapy and to observe the changes of tumor immune microenvironment in patients with locally advanced gastric or gastroesophageal junction cancer (T3-4NXM0).
Read the detailed description
For advanced gastric cancer, standard treatment is D2 gastrectomy combined with perioperative medications, when the tumor is infiltrating into submucosa, around or with lymph node metastasis, and can reduce the success rate of surgery, previous studies have showed a tumor on perioperative chemotherapy helps to drop period, and improve the long-term survival of patients, compared with surgery alone, It can improve the 5-year overall survival (OS) by about 10%. At present, SOX protocol is recommended as the perioperative protocol for advanced gastric cancer in domestic guidelines [5]. However, for patients with T3/T4 or positive lymph node (N+), the probability of recurrence or metastasis after resection is high, and the 5-year survival rate is only 23%. Previous studies have found that the prognosis of patients with complete pathological response or near complete pathological response after neoadjuvant chemotherapy is significantly improved, whereas the pCR rate is only less than 10%. It is an effective way to improve the prognosis of gastric cancer patients to seek neoadjuvant therapy that can improve the pathological response rate. Chemotherapy and immune checkpoint inhibitor drugs have a synergistic mechanism on the theoretical basis. Pd-1 inhibitors are a kind of immune checkpoint inhibitors. In the process of "immune escape" of tumors,PD-1 inhibitors are involved in the activation process of the immune system, and by inhibiting PD-1 receptors, T cells can be activated normally. Thus, the immune system of the body can promote the killing of tumor cells.
Our research group plans to carry out the study of carrelizumab (PD-1) combined with SOX/XELOX chemotherapy as a neoadjuvant therapy in locally advanced gastric cancer. A total of 34 patients with locally advanced gastric or gastroesophageal junction carcinoma of T3-4NXM0 were enrolled. After 3 cycles of carrelizumab (PD-1) combined with chemotherapy, radical resection was performed, and the treatment effect was evaluated by pathological remission of the surgical tissue. Collection and treatment of gastroscope biopsy tissue samples before and after neoadjuvant therapy surgery samples: 1. The multiple fluorescent immunohistochemical (mIHC) technique were used to detect the immune cells in tumor tissue infiltration, compared neoadjuvant therapy after curative effect before treatment between patients with good and poor effects of immune cell infiltration, the difference between a explore treatment response and the correlation between the baseline immune microenvironment; To compare the changes of immune cell infiltration before and after treatment, and to explore the effect of combined immunotherapy on the immune microenvironment of locally advanced gastric cancer. 2. High-throughput sequencing technology was used to sequence DNA molecules to compare the pre-treatment gene sequences between patients with good and poor efficacy after neoadjuvant therapy, and to explore the correlation between the effect of neoadjuvant therapy and gene sequence changes (dMMR, MSI, TMB, PD-L1, etc.).
- Conditions
- Locally Advanced Gastric Cancer
- Being tested
- Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine )
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine )Drug
Also called Camrelizumab + SOX / XELOX
Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine ) Drug: Camrelizumab 200mg Drug: oxaliplatin 130 mg/m2 Drug: Teggio 40 mg/m2 Drug: oxaliplatin 130 mg/m2 Drug: capecitabine 1000 mg/m2 Q3W for 3 cycles. Radical surgery was performed 3 weeks after the last neoadjuvant treatment.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine ) | Experimental | Camrelizumab + SOX / XELOX Receives: Drug: Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR, Becker criteria, TRG 1A)
It was evaluated according to tumor regression grade (Becker standard) : TRG1a had no residual cancer; TRG1b < 10% residual cancer; TRG2 10%-50% residual cancer; TRG3 > 50% residual cancer.
Measured: Up to approximately 6 months.
Secondary outcomes (2)
Major pathological response rate (MPR, TRG1a/ B)
It was referred to Tumor Regression Grade (Becker Standard) as above.
Measured: Up to approximately 6 months.
R0 resection rate and objective response rate (ORR, RECIST 1.1)
It was evaluated using the Response Assessment criteria for Solid tumors (RECIST 1.1). Subjects were required to have a measurable tumor lesion at baseline, and the outcome was classified as complete response (CR), partial response (PR), stable response (SD), and progressive response (PD) according to RECIST 1.1 criteria. Immune-related pseudoresults needed to be reconfirmed. During the screening period, baseline tumor imaging evaluation was completed within 4 weeks before the first treatment.Clinical tumor imaging evaluation was performed every 2 weeks during treatment. If disease progression was first reported according to RECIST 1.1, a clinical imaging confirmation was required 4 weeks later according to irRC. Investigators may add unplanned tumor imaging as clinically necessary.
Measured: Up to approximately 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start20 Sep 2022
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (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.
- 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Hongbo Wei, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Hongbo Wei, M.D., Ph.D., Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545436
- Sponsor's protocol ID
- （2022）02-181-01
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Prospective Single-arm Study of the Efficacy of Carrelizumab (PD-1) Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Gastric Cancer and Its Effect on Tumor Immune Microenvironment
- ClinicalTrials.gov ID
- NCT05545436
- Acronym / sponsor ID
- （2022）02-181-01
- Conditions
- Locally Advanced Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, open, exploratory clinical study to evaluate the efficacy of carrelizumab (PD-1) combined with chemotherapy (SOX/XELOX) as neoadjuvant therapy and to observe the changes of tumor immune microenvironment in patients with locally advanced gastric or gastroesophageal junction cancer (T3-4NXM0).
Detailed description
For advanced gastric cancer, standard treatment is D2 gastrectomy combined with perioperative medications, when the tumor is infiltrating into submucosa, around or with lymph node metastasis, and can reduce the success rate of surgery, previous studies have showed a tumor on perioperative chemotherapy helps to drop period, and improve the long-term survival of patients, compared with surgery alone, It can improve the 5-year overall survival (OS) by about 10%. At present, SOX protocol is recommended as the perioperative protocol for advanced gastric cancer in domestic guidelines [5]. However, for patients with T3/T4 or positive lymph node (N+), the probability of recurrence or metastasis after resection is high, and the 5-year survival rate is only 23%. Previous studies have found that the prognosis of patients with complete pathological response or near complete pathological response after neoadjuvant chemotherapy is significantly improved, whereas the pCR rate is only less than 10%. It is an effective way to improve the prognosis of gastric cancer patients to seek neoadjuvant therapy that can improve the pathological response rate. Chemotherapy and immune checkpoint inhibitor drugs have a synergistic mechanism on the theoretical basis. Pd-1 inhibitors are a kind of immune checkpoint inhibitors. In the process of "immune escape" of tumors,PD-1 inhibitors are involved in the activation process of the immune system, and by inhibiting PD-1 receptors, T cells can be activated normally. Thus, the immune system of the body can promote the killing of tumor cells.
Our research group plans to carry out the study of carrelizumab (PD-1) combined with SOX/XELOX chemotherapy as a neoadjuvant therapy in locally advanced gastric cancer. A total of 34 patients with locally advanced gastric or gastroesophageal junction carcinoma of T3-4NXM0 were enrolled. After 3 cycles of carrelizumab (PD-1) combined with chemotherapy, radical resection was performed, and the treatment effect was evaluated by pathological remission of the surgical tissue. Collection and treatment of gastroscope biopsy tissue samples before and after neoadjuvant therapy surgery samples: 1. The multiple fluorescent immunohistochemical (mIHC) technique were used to detect the immune cells in tumor tissue infiltration, compared neoadjuvant therapy after curative effect before treatment between patients with good and poor effects of immune cell infiltration, the difference between a explore treatment response and the correlation between the baseline immune microenvironment; To compare the changes of immune cell infiltration before and after treatment, and to explore the effect of combined immunotherapy on the immune microenvironment of locally advanced gastric cancer. 2. High-throughput sequencing technology was used to sequence DNA molecules to compare the pre-treatment gene sequences between patients with good and poor efficacy after neoadjuvant therapy, and to explore the correlation between the effect of neoadjuvant therapy and gene sequence changes (dMMR, MSI, TMB, PD-L1, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine ) | Experimental | Drug: Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine )Camrelizumab + SOX / XELOX |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- T3-4NxM0 locally advanced gastric or gastroesophageal junction carcinoma was confirmed by gastroscopic biopsy, CT and pathological examination;
- No previous systematic treatment for the current disease;
- Age ≥ 70 years, age ≥18 years, both sexes;
- ECOG physical status score 0-1; Full organ and bone marrow function:
- Blood routine: hemoglobin ≥90g/L, neutrophil count ≥1.5×10^9/L, platelet count ≥75×10^9/L; Liver function: serum total bilirubin ≤1.5× upper normal value (UNL), aspartate transferase ≤3×UNL, alanine Acid transferase ≤3×UNL; Renal function: serum creatinine ≤1.5×UNL, creatinine clearance rate ≥50ml/min; Coagulation function: INR, APTT and PT ≤1.5×UNL; Serum albumin ≥30g/L; Thyrotropin (TSH) and free thyroxine (fT4) were within the range of normal ±10%.
Key exclusion criteria (9 listed)
- People with allergic disease, history of severe drug allergy, known allergy to macromolecular protein preparations or carrelizumab;
- Early gastric cancer;
- Gastric cancer patients with HER2 amplification by pathological gene detection;
- History of other malignancies (except cured basal cell carcinoma of the skin, cured cervix) with disease-free survival <5 years Carcinoma in situ and gastrointestinal neoplasms proven to be cured by endoscopic mucosal resection);
- The presence or history of any active autoimmune disease (including but not limited to: interstitial pneumonia, Uveitis, enteritis, nephritis, hyperthyroidism, hypothyroidism);
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 + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine )Also: Camrelizumab + SOX / XELOXCamrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine ) Drug: Camrelizumab 200mg Drug: oxaliplatin 130 mg/m2 Drug: Teggio 40 mg/m2 Drug: oxaliplatin 130 mg/m2 Drug: capecitabine 1000 mg/m2 Q3W for 3 cycles. Radical surgery was performed 3 weeks after the last neoadjuvant treatment. | Drug | Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine ) |
Primary outcome
Pathological complete response rate (pCR, Becker criteria, TRG 1A)
Time frame: Up to approximately 6 months.
It was evaluated according to tumor regression grade (Becker standard) : TRG1a had no residual cancer; TRG1b < 10% residual cancer; TRG2 10%-50% residual cancer; TRG3 > 50% residual cancer.
2 secondary outcomes
Major pathological response rate (MPR, TRG1a/ B)
Time frame: Up to approximately 6 months.
R0 resection rate and objective response rate (ORR, RECIST 1.1)
Time frame: Up to approximately 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
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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.
Hongbo Wei, M.D., Ph.D. principal investigator
Third Affiliated Hospital, Sun Yat-Sen 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 + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine ) in people with Locally Advanced Gastric Cancer, run by Third Affiliated Hospital, Sun Yat-Sen 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 10 inclusion and 9 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 22 Sep 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?
Contact Hongbo Wei, M.D., Ph.D. (86-13060620467, drweihb@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR, Becker criteria, TRG 1A) (time frame: Up to approximately 6 months.). 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 22 Sep 2022.