Metastatic Colorectal Cancer (mCRC)
Conditions
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.
Interventions
DRUGSHR-1701、 BP102 、XELOX
Phase 2：Single Group Drug:SHR-1701 30mg/kg，IV ,every 3 week Drug：BP102 7.5mg/kg，IV,every 3 week Drug: Oxaliplatin 130mg/m2 ，IV,every 3 week Drug:Capecitabine The total daily dose was 2000mg/m2, OR，Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days
DRUGplacebo、 BP102、 XELOX
Phase 3：Randomized Drug:Placebo 30mg/kg，IV ,every 3 week Drug：BP102 7.5mg/kg，IV,every 3 week Drug: Oxaliplatin 130mg/m2 ，IV,every 3 week Drug:Capecitabine The total daily dose was 2000mg/m2, OR，Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2:ORR | up to 2 years | Objective response rate (assessed by the investigators based on RECIST v1.1) |
| Phase 2:Incidence of Adverse Events (AEs) by CTCAE v5.0 | up to 2 years | Assess safety and tolerability of SHR-1701 in combination with BP102 and XELOX |
| Phase 3:PFS | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years | Progression-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR | up to 2 years | Disease control rate，the proportion of patients with the best overall response of CR, PR, or stable disease (SD) 。 |
| Duration of response | up to 2 years | Duration of response，from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed |
| OS | up to 2 years | Overall survival ，from the date of first dose unitl the date of death from any cause。 |
| PFS | up to 2 years | Progression-free survival from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed (assessed by independent radiological review committee (IRRC) based on iRECIST，by the investigators based on RECIST v1.1))。 |
Countries
China
Outcome results
None listed