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Trial Title:
Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the Treatment of Advanced Gastric and Esophageal Cancer
NCT ID:
NCT06247956
Condition:
Advanced Gastric Adenocarcinoma and Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Esophageal Neoplasms
Esophageal Squamous Cell Carcinoma
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Capecitabine
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection
Description:
SHR-8068: Specified dose on specified days. Adebrelimab: Specified dose on specified
days. Oxaliplatin: Specified dose on specified days. Capecitabine Tablets: Specified dose
on specified days. Paclitaxel Injection: Specified dose on specified days. Cisplatin
Injection: Specified dose on specified days.
Arm group label:
SHR-8068 combined with adebrelimab and platinum-containing chemotherapy
Intervention type:
Drug
Intervention name:
Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection
Description:
Adebrelimab: Specified dose on specified days. Oxaliplatin Injection: Specified dose on
specified days. Capecitabine Tablets: Specified dose on specified days. Paclitaxel
Injection: Specified dose on specified days. Cisplatin Injection: Specified dose on
specified days.
Arm group label:
Adebrelimab combined with platinum-containing chemotherapy
Summary:
Objective response rate (ORR) was evaluated to evaluate the efficacy of SHR-8068 combined
with adebrelimab and platinum-containing chemotherapy in first-line treatment of advanced
gastric and esophageal cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Volunteer to join the clinical study, and sign the informed consent, compliance is
good, can cooperate with follow-up;
2. Aged 18-75 at the time of signing the informed consent;
3. Histologically or cytologically confirmed, unresectable, advanced or
recurrent/metastatic adenocarcinoma of the gastric or gastroesophageal junction, or
unresectable or recurrent/metastatic esophageal squamous cell carcinoma without
radical chemoradiation;
4. At least one measurable lesion consistent with RECIST v1.1;
5. ECOG PS score: 0-1;
6. The organ function level is good;
Exclusion Criteria:
1. Her2-positive patients;
2. Untreated (radiation or surgery) central nervous system metastasis, or accompanied
by meningeal metastasis, spinal cord compression, etc.;
3. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with
clinical symptoms;
4. Previous or co-existing malignant neoplasms;
5. The presence of any active or known autoimmune disease;
6. People who have previously received an organ transplant;
7. Have clinical symptoms or diseases of the heart that are not well controlled;
8. Known allergic reactions to adebrelimab or other monoclonal antibodies or
investigational drugs;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese PLA General Hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Investigator:
Last name:
Jianming Xu
Email:
Principal Investigator
Start date:
March 11, 2024
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06247956
