Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the Treatment of Advanced Gastric and Esophageal Cancer

A Randomized, Open, Multicenter Phase II Clinical Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the First-line Treatment of Advanced Gastric and Esophageal Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06247956

Enrollment

153

Registered

2024-02-08

Start date

2024-03-11

Completion date

2025-12-30

Last updated

2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Gastric Adenocarcinoma and Esophageal Squamous Cell Carcinoma

Brief 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.

Interventions

DRUGSHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection

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.

DRUGAdebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection

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.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
ORR based on RECIST v1.1 assessment.	All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years

Secondary

Measure	Time frame
DCR based on RECIST v1.1 assessment	All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026