Neoadjuvant Safety of Sintilimab + XELOX + Bevacizumab in pMMR/MSS CRLM Patients

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    30
  • sponsor
    Sun Yat-sen University
Updated on 2 July 2021

Summary

This prospective, single arm study aims to evaluate the preoperative neoadjuvant safety of Sintilimab combined with XELOX plus bevacizumab in colorectal patients with liver metastasis and pMMR/MSS status.

Description

PRIMARY OBJECTIVES:

This preliminary prospective study aims to evaluate the safety of neoadjuvant treatment combination of Sintilimab, XELOX and bevacizumab and also asses safety during surgery of colorectal patients with liver metastasis and pMMR/MSS status.

SECONDARY OBJECTIVES:

To evaluate Pathological Remission Rate (pCR/MPR/PR rate), Objective Response Rate (ORR), Recurrence Free Survival (RFS) and Overall Survival (OS).

EXPLORATORY OBJECTIVES:

Analysis of liver metastasis before and after treatment to compare molecular and immunophenotypic changes.

OUTLINE

Patients receive Sintilimab + XELOX regimen every 3 weeks for 4 cycles and Bevacizumab every 3 weeks for 2 cycles. After which if there are no new lesions upon assessment, radical surgery is performed within 6 weeks after neoadjuvant treatment. After surgery 4 cycles of XELOX regimen is advised for adjuvant therapy.

Details
Condition Colorectal Cancer Metastatic, Metastatic Colorectal Cancer
Treatment Capecitabine, bevacizumab, Oxaliplatin, Sintilimab
Clinical Study IdentifierNCT04940546
SponsorSun Yat-sen University
Last Modified on2 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years old and 75 years old
Histologically confirmed colorectal adenocarcinoma
Radiologically and/or pathologically confirmed liver metastasis
Immunohistochemistry and/or genetic testing confirmed pMMR/MSS
Absence of extrahepatic metastasis confirmed by CT, MRI or PET/CT (if necessary)
Primary lesion has been or can be removed by radical surgery
Liver metastases can be resected (or using intraoperative radiofrequency) and is expected to achieve tumor-free status (NED) after surgery. Resectable liver metastases are defined explicitly as less than 5 metastatic lesions; R0 resection is achievable by resection or intraoperative radiofrequency; Remaining liver volume is expected to be sufficient after surgery; The following can be retained after resection: One hepatic vein, preserve blood flow in and out of the remaining liver, the bile duct, and at least 2 adjacent livers segments There is no extrahepatic metastasis
Apart from surgical resection of the primary lesion, he/she has not received any anti-tumor treatment for liver metastasis (including chemotherapy, targeted drugs, interventional therapy, immunotherapy, radiotherapy, etc.)
Normal hematological function (platelets>90109/L; white blood cells>3109/L; neutrophils>1.5109/L)
Serum bilirubin 1.5 times the upper limit of normal (ULN), transaminase 5 times ULN, alkaline phosphatase 2.5 ULN, No ascites, normal coagulation function, albumin 35g/L
Child-Pugh classification of the liver is A
Serum creatinine is less than the upper limit of normal (ULN), or the calculated creatinine clearance rate is greater than 50ml/min (using Cockcroft-Gault formula)
ECOG score 0-1
Life expectancy> 3 months
Signed and written informed consent
Willing and able to follow up until death or the end of the study or the study is terminated

Exclusion Criteria

Presence of distant metastases outside the liver after the diagnosis of colorectal cancer
Liver metastases have been treated with chemotherapy, targeted drugs, intervention, immunotherapy, radiotherapy, etc
No surgical resection plan for liver metastases
Received oxaliplatin-containing adjuvant chemotherapy in the past 1 year
Any residual toxicity from previous chemotherapy (except for hair loss), such as peripheral neuropathy NCI CTC v3.0 Grade 2
Use of immunosuppressive drugs within 1 week before treatment, not including nasal sprays, inhalation or other local treatments, partial glucocorticoids or physiological doses of systemic glucocorticoids (i.e. not more than 10 mg/day prednisone or equivalent doses of other glucocorticoids) or use of corticoids to prevent contrast agent allergy
Suffering from interstitial lung disease that requires steroid therapy
Medical history of active autoimmune disease that needs symptomatic treatment within the past 2 years. Vitiligo, psoriasis, hair loss, or Grave's disease that do not require systemic treatment within the past 2 years, or hypothyroidism patients that only need thyroid hormone replacement therapy and type I diabetic patients requiring only insulin replacement therapy can be enrolled
History of primary immunodeficiency
Active tuberculosis
Known history of allergies related to organ transplantation or hematopoietic stem cell transplantation
Allergic to any monoclonal antibody or chemotherapeutic drug (fluorouracil, oxaliplatin) and its ingredients
Have bleeding tendency or coagulopathy
Patients with apparent symptoms of intestinal obstruction
Hypertensive crisis or hypertensive encephalopathy
Serious uncontrollable systemic complications such as infection or diabetes
Clinically severe cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (enrollment within the first 6 months), uncontrollable hypertension, unstable angina pectoris, heart failure (NYHA 2-4), arrhythmia requiring medical treatment
Presence of central nervous system disease ( such as primary brain tumor, history of uncontrollable epilepsy, any brain metastases or stroke)
Suffered from other malignant tumors in the past 5 years (except resected skin basal cell carcinoma and/or cervical carcinoma in situ)
Received any drug treatment used for this study in the last 28 days
Women who are pregnant and breastfeeding. Women of childbearing age who do not use or refuse to use effective non-hormonal contraceptive methods (intrauterine contraceptive ring, barrier contraception combined with spermicidal gel or female sterilization ) (<2 years after the last menstruation) or men with childbearing potential who are unable or unwilling to comply with the research protocol
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