Clinical trial NCT05101616: A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer
Official title: A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer: a Single-center, Open-label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer
Keywords: gastric cancer
neoadjuvant chemotherapy
immunotherapy
Lead sponsor: Shanghai Minimally Invasive Surgery Center
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up;
2. Male or female patients between the ages of 18-75;
3. Patients diagnosed as gastric adenocarcinoma by histology or cytology;
4. Stage: Locally advanced stage (T3-4aN1-3M0);
5. Have not received other immunotherapy drugs or chemotherapy drugs in the past;
6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points;
7. Has sufficient organ and bone marrow function

Exclusion Criteria:

1. 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 \[Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)\];
2. A distant metastasis occurs;
3. Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
4. Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
5. Patients with any severe and/or uncontrollable disease；
6. 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
7. 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;
8. Received glucocorticosteroid or immunosuppressive therapy within 7 days before grouping;
9. 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
10. 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;
11. People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
12. Participated in other anti-tumor drug clinical trials within four weeks;
13. 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;
14. Female patients who are pregnant or breastfeeding;
15. Known hypersensitivity to any study drug.

Primary outcomes:
measure: major pathologic response rate
timeFrame: one month after surgery
Secondary outcomes:
measure: complete pathologic response rate
timeFrame: one month after surgery
measure: R0 resection rate
timeFrame: one month after surgery
measure: Overall survival
timeFrame: 3 years
measure: Disease-free survival
timeFrame: 3 years
measure: perioperative complications
timeFrame: the time from the start of randomization to 3 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References: