A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer

NCT ID: NCT05101616

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2027-01-01

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

camrelizumab+chemotherapy

neoadjuvant treatment with camrelizumab+chemotherapy

Group Type: EXPERIMENTAL

camrelizumab+chemotherapy

Intervention Type: DRUG

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.

chemotherapy

neoadjuvant treatment with chemotherapy

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Minimally Invasive Surgery Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

Camrelizumab-GC-neoadjuvant

Identifier Type: -

Identifier Source: org_study_id