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Fruquintinib Plus PD-1 Antibody in pMMR / MSS Locally Advanced Rectal Cancer (LARC) With High Immune Score | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Fruquintinib Plus PD-1 Antibody in pMMR / MSS Locally Advanced Rectal Cancer (LARC) With High Immune Score

Fruquintinib Combined With PD-1 Antibody in pMMR / MSS Locally Advanced Rectal Cancer (LARC) With High Immune Score: an Open-label, Multi-center, Phase II Clinical Trial

NCT04989855•Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a prospective, one arm phase II study aimed to observe the efficacy and safety of tislelizumab combined with fruquintinib in treatment of patients with pMMR / MSS locally advanced rectal cancer with high immune score.

Detailed Description

48 patients of pMMR / MSS locally advanced rectal cancer with high immune score will be administered with tislelizumab (200mg IV d1, Q3W ) combined with fruquintinib (5mg QD d1-d14, Q3W) with a total of 2 cycles as neoadjuvant therapy. After TME, tislelizumab and fruquintinib will be given again for up to 6 months as adjuvant therapy. If the patient after neoadjuvant therapy is evaluated as SD/PD, the neoadjuvant therapy will be converted to neoadjuvant chemo-radiotherapy/chemotherapy or palliative therapy, and then the patient will be treated according to the norms of adjuvant therapy for rectal cancer if TME is performed. If the patient choose Watch \& Wait when evaluated as CR, tislelizumab plus fruquintinib for at least one year is requested.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18-75 yrs old;
•2. pMMR/MSS rectal adenocarcinoma;
•3. Pelvic MRI / endoscopic ultrasonography or transrectal ultrasound were used for reoperative staging: T3-4N+ with resectable tumor;
•4. High immune score (Immunoscore®️ ≥3);
•5. No sign of bowel obstruction, or bowel obstruction has been relieved by ostomy;
•6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
•7. No previous chemotherapy, radiotherapy or immunotherapy;
•8. Distant metastasis was excluded by CT of chest, abdomen and pelvis before operation;
•9. Able to swallow tablets;
•10. Life expectancy of at least 2 years;
+2 more criteria

Exclusion Criteria

•1. Any active autoimmune disease or history of autoimmune disease;
•2. Immunosuppressants, systemic or absorbable local hormones are being used to achieve the purpose of immunosuppression (dose \> 10mg / day, prednisone or other effective hormones) and continue to be used within 2 weeks before enrollment;
•3. History of severe allergic reaction to monoclonal antibody;
•4. Subjects with untreated active brain metastasis or meningeal metastasis with clinical symptoms;
•5. Suffering from hypertension and can not be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg);
•6. Have previously received other PD-1 antibody therapy or other immunotherapy against PD-1 / PD-L1, or have previously received anti angiogenesis drugs;
•7. There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) heart failure above NYHA grade 2 (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
•8. Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or undergoing thrombolytic or anticoagulant therapy;
•9. Urine routine examination indicates that urinary protein is ≥ + +, or confirmed 24-hour urinary protein is ≥ 1.0g;
•10. Significant clinical bleeding symptoms or definite bleeding tendency occurred within 3 months before enrollment, such as gastrointestinal bleeding, active bleeding, baseline fecal occult blood + + or above, or vasculitis;
+10 more criteria

Locations (1)

651 Dongfeng Road East

Guangzhou, Guangdong, China

Key Dates

Start Date

August 1, 2021

Primary Completion Date

August 1, 2022

Completion Date

February 1, 2024

Last Updated

August 4, 2021

Enrollment

ESTIMATED participants

Conditions

Locally Advanced Rectal Cancer

Interventions

Fruquintinib plus Tislelizumab

DRUG

Contacts

Pei-Rong Ding, M.D.

CONTACT

8602087343920 dingpr@sysucc.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 4, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Fruquintinib Plus PD-1 Antibody in pMMR / MSS Locally Advanced Rectal Cancer (LARC) With High Immune Score

Inclusion Criteria

Exclusion Criteria

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

A Pospective, Single-arm, Multicenter Clinical Trial Evaluating Preoperative Neoadjuvant mFOLFOX6 Chemotherapy in Combination With PD1 Monoclonal Antibody in MSS/pMMR Locally Advanced Rectal Cancer

Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer