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

NCT05101616 | Suspended Phase 1

• 1 other identifier: Camrelizumab-GC-neoadjuvant
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

gastric cancer; neoadjuvant chemotherapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• major pathologic response rate

  complete or subtotal regression (\<10% residual tumor per tumor bed)

  one month after surgery

Secondary Outcomes (5)

• complete pathologic response rate

  one month after surgery

• R0 resection rate

  one month after surgery

• Overall survival

  3 years

• Disease-free survival

  3 years

• perioperative complications

  the time from the start of randomization to 3 months after surgery

Study Arms (2)

camrelizumab+chemotherapy

EXPERIMENTAL

neoadjuvant treatment with camrelizumab+chemotherapy

Drug: camrelizumab+chemotherapy

chemotherapy

ACTIVE COMPARATOR

neoadjuvant treatment with chemotherapy

Drug: Chemotherapy

Interventions

camrelizumab+chemotherapy 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.

camrelizumab+chemotherapy

Chemotherapy 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.

chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Minimally Invasive Surgery Center: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 1, 2021
• Study Start: July 1, 2022
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

CN (1)