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AzTrials

Colorectal Cancer MetastaticPhase 1/2NCT04940546

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

A Phase 1/2 study testing Sintilimab, Oxaliplatin and Capecitabine in people with Colorectal Cancer Metastatic, run by Sun Yat-sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
Sintilimab, Oxaliplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
16 Jun 2021to 30 Oct 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 ① less than 5 metastatic lesions; ② R0 resection is achievable by resection or intraoperative radiofrequency; ③ Remaining liver volume is expected to be sufficient after surgery; ④ 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 ⑤ 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>90×109/L; white blood cells>3×109/L; neutrophils>1.5×109/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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Prospective Safety Study of Sintilimab Combined with XELOX Plus Bevacizumab for Preoperative Neoadjuvant Therapy of CRLM Patients with PMMR/MSS Status

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.

Read the detailed 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.

Keywords
Colorectal liver metastasis, pMMR/MSS, Sintilimab, XELOX, Bevacizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SintilimabDrug

    Also called Anti-PD-1 monoclonal antibody IBI308

    Mode of administration: Intravenously

  • OxaliplatinDrug

    Also called Eloxatin

    Mode of administration: Intravenously

  • CapecitabineDrug

    Also called Xeloda

    Mode of administration: Orally

  • BevacizumabDrug

    Also called Avastin

    Mode of administration: Intravenously

Study groups in NCT04940546
Study groupRoleWhat they receive
Sintilimab + XELOX + BevacizumabExperimentalPatients receive Sintilimab + XELOX regimen every 3 weeks for 4 cycles and Bevacizumab every 3 weeks for 2 cycles. Details are as follows: Sintilimab: 200mg intravenously, d1 Oxaliplatin: 135mg/m2 intravenously, d1 Capecitabine: 2g/m2 orally, d1-14 for Bevacizumab: 7.5mg/kg intravenously, d1 After neoadjuvant treatment, if there are no new lesions upon radiological and Multidisciplinary Team (MDT) assessment, radical surgery is performed within 6 weeks. If there are new lesions the surgical team will assess the optimal time for surgery. After surgery 4 cycles of XELOX regimen is advised for adjuvant therapy.
Receives: Drug: Sintilimab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Number of patients with adverse events and severity according to NCICTCAE v5.0 during treatment period and using Clavien-Dindo classification of surgical complications for surgery.

    Measured: up to 24 months

Secondary outcomes (4)

  1. Pathological Remission Rate

    Assessment of the absence of residual tumor pathologically

    Measured: up to 24 months

  2. Objective Response Rate

    Evaluation of changes in tumor size using the RECIST 1.1 criteria

    Measured: up to 24 months

  3. Recurrence Free Survival

    The length of time during and after the treatment of the disease, that a patient lives with the disease without recurrence

    Measured: up to 24 months

  4. Overall Survival

    The length of time from the start of treatment that patients diagnosed are still alive

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2021
  2. Study start16 Jun 2021
  3. Primary completion30 Oct 2023
  4. Study completion30 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04940546
Sponsor's protocol ID
neoSXB-MSS-CRLM
Status last verified
Nov 2024
First submitted
18 Jun 2021
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sintilimab, Oxaliplatin and Capecitabine in people with Colorectal Cancer Metastatic, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04940546.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.

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