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

Last updated: March 5, 2024
Sponsor: Shanghai Minimally Invasive Surgery Center
Overall Status: Suspended

Phase

1/2

Condition

Gastric Cancer

Digestive System Neoplasms

Stomach Cancer

Treatment

Chemotherapy

camrelizumab+chemotherapy

Clinical Study ID

NCT05101616
Camrelizumab-GC-neoadjuvant
  • Ages 18-75
  • All Genders

Study 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

Inclusion Criteria:

  1. Subjects voluntarily join the study and sign an informed consent form, have goodcompliance 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

Exclusion Criteria:

  1. Other malignant tumors that have appeared or are currently suffering from within 5years, except for cured cervical carcinoma in situ, non-melanoma skin cancer andsuperficial 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 toswallow, chronic diarrhea, etc.);
  4. Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AEV5.0 grade ≥ 2 dyspnea);
  5. Patients with any severe and/or uncontrollable disease;
  6. Patients with gastrointestinal diseases with bleeding tendency (such as activegastrointestinal ulcers) or patients determined by the researcher to causegastrointestinal bleeding, perforation or obstruction
  7. Patients whose imaging shows that the tumor has invaded the tissues around importantblood vessels or the investigator judges that the tumor is likely to invade importantblood vessels and cause fatal bleeding during the follow-up study;
  8. Received glucocorticosteroid or immunosuppressive therapy within 7 days beforegrouping;
  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-CTCAE V5.0 grade ≥ 3, unhealed wounds, ulcers Or fracture
  10. Those who have had arterial/venous thrombotic events within 6 months, such ascerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosisand pulmonary embolism;
  11. People with a history of psychotropic drug abuse and unable to quit or have mentaldisorders;
  12. Participated in other anti-tumor drug clinical trials within four weeks;
  13. According to the judgment of the investigator, those with concomitant diseases thatseriously 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.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Chemotherapy
Phase: 1/2
Study Start date:
July 01, 2022
Estimated Completion Date:
January 01, 2027

Connect with a study center

  • Ruijin Hospital

    Shanghai, Shanghai 200025
    China

    Site Not Available

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