Clinical trial NCT04856787: A Clinical Studyf of SHR-1701 or Placebo in Combination With BP102 and XELOX in the First-line Treatment of mCRC
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Study of SHR-1701 or Placebo in Combination With BP102 (Biosimilar to Bevacizumab) and XELOX in First-line Treatment of mCRC
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Metastatic Colorectal Cancer (mCRC)
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 bevacizumab) and XELOX in first-line treatment of patients with mCRC.


Eligibility criteria: Inclusion Criteria:

1. Patients with unresectable recurrent or metastatic adenocarcinoma of the colon or rectum confirmed histologically
2. 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
3. At least 1 measurable lesion according to RECIST V1.1
4. The vital organs are functioning well
5. ECOG score is 0 \~ 1
6. Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug

Exclusion Criteria:

1. Recurrent or metastatic lesions can be treated with radical surgery
2. Presence of central nervous system or meningeal metastases;
3. Moderate and severe ascites of clinical symptoms;Uncontrolled or moderate or greater pleural effusion or pericardial effusion
4. 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
5. 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
6. Subject with current interstitial pneumonia or interstitial lung disease, or with a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy
7. Previous treatment with targeted T cell costimulatory molecules and immune checkpoint inhibitors;Previous treatment with antiepidermal growth factor receptor or any antiangiogenic drug

Primary outcomes:
measure: Phase 2:ORR
timeFrame: up to 2 years
measure: Phase 2:Incidence of Adverse Events (AEs) by CTCAE v5.0
timeFrame: up to 2 years
measure: Phase 3:PFS
timeFrame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
Secondary outcomes:
measure: DCR
timeFrame: up to 2 years
measure: OS
timeFrame: up to 2 years
measure: PFS
timeFrame: up to 2 years
measure: Duration of response
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: