Actively Recruiting
A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2025-01-03
148
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer. To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Esophageal Cancer
CONDITIONS
Official Title
A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent and follow the treatment and testing plan
- Age between 18 and 70 years, any gender
- Provide archived or fresh tumor tissue for testing
- Have at least one measurable tumor lesion by RECIST v1.1 criteria
- Diagnosed with locally advanced unresectable or metastatic esophageal squamous cell carcinoma
- ECOG performance status of 0 or 1
- Expected survival of 12 weeks or more
- Good organ function
- Use effective contraception if sexually active and of reproductive potential
You will not qualify if you...
- Untreated or uncontrolled active central nervous system metastases
- Uncontrolled tumor-related pain
- Moderate or severe ascites needing recent drainage or significant pleural/pericardial effusion
- History of gastrointestinal perforation or fistula within 6 months
- Prior antitumor therapy within 4 weeks before study start
- Previous antibody drugs with topoisomerase I inhibitors
- Use of certain enzyme boosters or inducers within 5 drug half-lives before first dose
- Recent major surgeries or expected elective surgeries during the study
- Recent radiation therapy above specified doses before dosing
- Ongoing toxicity from prior treatments above grade 1
- Recent live attenuated vaccines
- Recent immunosuppressive therapy
- Known or suspected interstitial pneumonia
- Significant recent blood loss
- Severe cardiovascular or cerebrovascular disease
- Recent arterial or venous thrombosis
- Other malignancies
- Severe infections within 28 days before dosing
- Active hepatitis B or C
- Active pulmonary tuberculosis within 1 year
- History of immune deficiency
- Severe allergy to study drugs
- Other conditions increasing risk or interfering with study participation per investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
Z
Zongyan Xie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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