Status:
TERMINATED
A Clinical Studyf of SHR-1701 or Placebo in Combination With BP102 and XELOX in the First-line Treatment of mCRC
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Metastatic Colorectal Cancer (mCRC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a two-arm, randomized, double-blinded, multicenter phase II/III clinical study to evaluate the safety and clinical efficacy of SHR-1701 or placebo in combination with BP102 (biosimilar to beva...
Eligibility Criteria
Inclusion
- Patients with unresectable recurrent or metastatic adenocarcinoma of the colon or rectum confirmed histologically
- For subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be ≥12 months after the last administration of neoadjuvant or adjuvant therapy
- At least 1 measurable lesion according to RECIST V1.1
- The vital organs are functioning well
- ECOG score is 0 \~ 1
- Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug
Exclusion
- Recurrent or metastatic lesions can be treated with radical surgery
- Presence of central nervous system or meningeal metastases;
- Moderate and severe ascites of clinical symptoms;Uncontrolled or moderate or greater pleural effusion or pericardial effusion
- Poorly controlled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg in the case of regular antihypertensive therapy) and prior hypertensive crisis or hypertensive encephalopathy
- Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlledSubjects with a history of myocardial infarction or unstable angina pectoris
- Subject with current interstitial pneumonia or interstitial lung disease, or with a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy
- Previous treatment with targeted T cell costimulatory molecules and immune checkpoint inhibitors;Previous treatment with antiepidermal growth factor receptor or any antiangiogenic drug
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04856787
Start Date
June 22 2021
End Date
April 17 2024
Last Update
May 18 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060