A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer
Study Details
Study Description
Brief Summary
It is a single-center, open-lable, randomized controlled trial to prospectively investigate the effectiveness and safety of Camrelizumab combined with DOS regimen chemotherapy in neoadjuvant treatment of patients with locally advanced gastric cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: camrelizumab+chemotherapy neoadjuvant treatment with camrelizumab+chemotherapy |
Drug: camrelizumab+chemotherapy
camrelizumab 200mg，ivdrip，q3w； albumin nanoparticle of paclitaxel 260 mg/m2、 ivdrip，d1，q3w； oxaliplatine 85mg/m2、ivdrip，d1，q3w； S-1 40 mg/m2，po, bid，d1~d14，q3w. 3 cycles.
|
| Active Comparator: chemotherapy neoadjuvant treatment with chemotherapy |
Drug: Chemotherapy
albumin nanoparticle of paclitaxel 260 mg/m2、 ivdrip，d1，q3w； oxaliplatine 85mg/m2、ivdrip，d1，q3w； S-1 40 mg/m2，po, bid，d1~d14，q3w. 3 cycles.
|
Outcome Measures
Primary Outcome Measures
- major pathologic response rate [one month after surgery]
complete or subtotal regression (<10% residual tumor per tumor bed)
Secondary Outcome Measures
- complete pathologic response rate [one month after surgery]
complete regression (no residual tumor per tumor bed)
- R0 resection rate [one month after surgery]
surgically removed tissue without residual cancer cells
- Overall survival [3 years]
the time from the start of randomization to death due to any cause.
- Disease-free survival [3 years]
the time from the start of randomization to the incurable resection, local recurrence or metastasis, or death from any cause.
- perioperative complications [the time from the start of randomization to 3 months after surgery]
perioperative complications
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up;
-
Male or female patients between the ages of 18-75;
-
Patients diagnosed as gastric adenocarcinoma by histology or cytology;
-
Stage: Locally advanced stage (T3-4aN1-3M0);
-
Have not received other immunotherapy drugs or chemotherapy drugs in the past;
-
ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points;
-
Has sufficient organ and bone marrow function
Exclusion Criteria:
-
Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)];
-
A distant metastasis occurs;
-
Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
-
Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
-
Patients with any severe and/or uncontrollable disease；
-
Patients with gastrointestinal diseases with bleeding tendency (such as active gastrointestinal ulcers) or patients determined by the researcher to cause gastrointestinal bleeding, perforation or obstruction
-
Patients whose imaging shows that the tumor has invaded the tissues around important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
-
Received glucocorticosteroid or immunosuppressive therapy within 7 days before grouping;
-
Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers Or fracture
-
Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
-
People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
-
Participated in other anti-tumor drug clinical trials within four weeks;
-
According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study;
-
Female patients who are pregnant or breastfeeding;
-
Known hypersensitivity to any study drug.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruijin Hospital | Shanghai | Shanghai | China | 200025 |
Sponsors and Collaborators
- Shanghai Minimally Invasive Surgery Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Camrelizumab-GC-neoadjuvant