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Surufatinib Combined With Sintilimab for Advanced MSS-Type Colorectal Cancer : a Phase II Study

NCT ID: NCT04764006

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-13

Study Completion Date

2023-11-01

Brief Summary

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A phase II study to assess the efficacy and safety of Surufatinib combined with Sintilimab as a second-line treatment in patients with advanced MSS-Type CRC.

Detailed Description

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Conditions

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Advanced Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surufatinib plus Sintilimab

Drug: Surufatinib plus Sintilimab Surufatinib will be given orally. Sintilimab will be given intravenously

Group Type EXPERIMENTAL

Surufatinib

Intervention Type DRUG

Surufatinib(250mg ,qd,po)+Sintilimab(200mg,q3w,iv),21 days for a cycle.The curative effect was evaluated every 8 weeks.

Interventions

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Surufatinib

Surufatinib(250mg ,qd,po)+Sintilimab(200mg,q3w,iv),21 days for a cycle.The curative effect was evaluated every 8 weeks.

Intervention Type DRUG

Other Intervention Names

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HMPL-012

Eligibility Criteria

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Inclusion Criteria

1. For inclusion in study, patient must provide a written informed consent.
2. Male or female, age18-75 years.
3. Pathologically confirmed unresectable locally advanced or advanced MSS-Type metastatic colorectal adenocarcinoma .
4. The patient had previously failed standard first-line systemic chemotherapy,Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) if 6 months or more have passed since completion of therapy.
5. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
6. Life expectancy \> 12 weeks.
7. Have measurable disease based on RECIST 1.1.

Exclusion Criteria

1. Any therapy with anti-PD-1, or anti-PD-L1/l2 antibodies or anti-cytotoxic T lymphocyte associated antigen-4 (CTLA-4) antibody (or any other antibody acting on T cell costimulatory or checkpoint pathway) or fruquintinib treatment in previous.
2. Prior receipt of Surufatinib.
3. History of any active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc. (except patients with hypothyroidism that can be controlled only by hormone replacement therapy and patients with type I diabetes who only need insulin replacement therapy).
4. History of gastrointestinal perforation and/or fistula, ileus, inflammatory bowel disease, or extensive enterotomy (partial colectomy or extensive enterotomy with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea within 6 months prior to first dosing.
5. Any life-threatening bleeding event or grade 3 or 4 bleeding requiring blood transfusion, endoscopy, or surgery with 3 months prior to dosing.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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China, Fujian

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zengqing Guo

Role: CONTACT

Phone: 86-13905918836

Email: [email protected]

Facility Contacts

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Zengqing Guo, MD

Role: primary

Other Identifiers

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HMPL-012-SPRING-C101

Identifier Type: -

Identifier Source: org_study_id