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

NCT ID: NCT04856787

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-22
• Study Completion Date: 2024-04-17

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.

Conditions

Metastatic Colorectal Cancer (mCRC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SHR-1701 in combination with BP102 and XELOX（Phase 2）

Group Type: EXPERIMENTAL

SHR-1701、 BP102 、XELOX

Intervention Type: DRUG

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

SHR-1701 in combination with BP102 and XELOX （Phase 3）

Group Type: EXPERIMENTAL

SHR-1701、 BP102 、XELOX

Intervention Type: DRUG

Phase 3：Randomized

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

placebo in combination with BP102 and XELOX

Group Type: PLACEBO_COMPARATOR

placebo、 BP102、 XELOX

Intervention Type: DRUG

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

Interventions

SHR-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

Intervention Type: DRUG

SHR-1701、 BP102 、XELOX

Phase 3：Randomized

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

Intervention Type: DRUG

placebo、 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

References

Qiu MZ, Bai Y, Wang J, Gu K, Yang M, He Y, Yi C, Jin Y, Liu B, Wang F, Chen YK, Dai W, Jiang Y, Huang C, Xu RH, Luo HY. Addition of SHR-1701 to first-line capecitabine and oxaliplatin (XELOX) plus bevacizumab for unresectable metastatic colorectal cancer. Signal Transduct Target Ther. 2024 Dec 16;9(1):349. doi: 10.1038/s41392-024-02063-0.

Reference Type: DERIVED

PMID: 39676137 (View on PubMed)

Other Identifiers

SHR-1701-III-301

Identifier Type: -

Identifier Source: org_study_id