A Clinical Studyf of SHR-1701 or Placebo in Combination With BP102 and XELOX in the First-line Treatment of mCRC

Phase 2

Terminated

• Conditions: Metastatic Colorectal Cancer (mCRC)
• Interventions: Drug: SHR-1701、 BP102 、XELOX; Drug: placebo、 BP102、 XELOX

• Registration Number: NCT04856787
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-23
• Study Start: 2021-06-22
• Primary Completion: 2024-04-17
• Study Completion: 2024-04-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-1701 in combination with BP102 and XELOX（Phase 2）	SHR-1701、 BP102 、XELOX	-
SHR-1701 in combination with BP102 and XELOX （Phase 3）	SHR-1701、 BP102 、XELOX	-
placebo in combination with BP102 and XELOX	placebo、 BP102、 XELOX	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
OS	up to 2 years	Overall survival ，from the date of first dose unitl the date of death from any cause。
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
DCR	up to 2 years	Disease control rate，the proportion of patients with the best overall response of CR, PR, or stable disease (SD) 。
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))。

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China