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Colorectal Cancer MetastaticNCT06456515

Regorafenib and Sintilimab in Combination with Electroacupuncture in MSS CRC

A study testing Regorafenib and Sintilimab in combination with electroacupuncture in people with Colorectal Cancer Metastatic, run by The First People's Hospital of Changzhou at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The aim of this clinical trial is to find out whether Regorafenib and Sintilimab in combination with electroacupuncture works in treating participants with microsatellite stable (MSS) advanced colorectal cancer who have failed one or more second-line standard chemotherapy regimens. 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?
Regorafenib and Sintilimab in combination with electroacupuncture
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 May 2024to Mar 2026
Phase
Interventional
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

  • Fullly knowledge of the study and voluntarily sign the informed consent;
  • Histologically and/or cytologically confirmed metastatic colorectal adenocarcinoma (Stage IV) with microsatellite stable (MSS)* confirmed by PCR or NGS;
  • Receive at least two lines of standard chemotherapy in the past and have failed.
  • No systemic chemotherapy or antitumor therapy such as radiotherapy, immunotherapy, biological or hormonal therapy in the past 4 weeks; and have never received VEGFR inhibitors
  • Willing to receive electroacupuncture;
  • Aged 18-75 years old (including 18 years old and 75 years old);
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  • Weighing more than 40 kg (including 40 kg);
  • Able to take oral medication.
  • Patients with adequate organ function at the time of enrollment are defined as follows: Neutrophil count ≥1500mm3 Platelet count ≥10.0 × 104/mm3 Hemoglobin (Hb) ≥ 9 g/dL Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤100 U/L (≤100 U/L in patients with hepatocellular carcinoma, ≤250 U/L in patients with liver metastasis) Total bilirubin ≤1.5 mg /dL Creatinine ≤1.5 mg /dL Lipase ≤ 80 IU/L Urine Protein: one of the following (if any of the criteria are met, no other test may be performed) (i) Urine Protein (paper test) of 2+ or less (ii) UPC < 3.5 (iii) Urine Protein ≦ 3500 mg for 24 hour urine protein measurements. mg Prothrombin time (PT)-International Normalized Ratio (INR): ≤ 1.5 (≤ 3.0 for anticoagulant administration)
  • Eastern Cooperative Oncology Group Physical Performance Score (ECOG PS) ≤ 1 (0-1);
  • Cardiac function evaluation: left ventricular ejection fraction ≥ 50% (echocardiography);
  • Clearly meet the criteria for evaluating the efficacy of solid tumors (e.g., echocardiograms) Measurable lesions that meet the requirements of RECIST 1.1;
  • Expected survival of more than 12 weeks.

Who cannot join

  • Patients will be excluded from the study if any of the following criteria are met.
  • Patients who have received systemic chemotherapy, radiotherapy, surgery, hormonal therapy or immunotherapy <2 weeks prior to enrolment. Immune checkpoint blockade pretreatment is permitted.
  • Patients with a history of regorafenib administration.
  • Patients with uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90 mmHg) despite multiple antihypertensive medications; and
  • Patients with acute coronary syndromes (including myocardial infarction and unstable angina) and a history of coronary angioplasty or stenting within 6 months prior to enrolment;
  • Patients with a large pleural effusion or ascites requiring drainage; and
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  • Patients with grade ≥ 3 active infection according to NCI CTC AE version 4.03; patients with symptomatic brain metastases; and patients with a history of coronary artery angioplasty or stenting within the previous 6 months.
  • Patients with symptomatic brain metastases;
  • Patients with partial or complete gastrointestinal obstruction;
  • Patients with interstitial lung disease with active signs or symptoms;
  • Patients who test positive for anti-HIV-1 antibody, anti-HIV-2 antibody, hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV)* *Patients who test positive for anti-hepatitis B surface (HBs) or anti-hepatitis B core (HBc) antibodies and patients with hepatitis B virus (HBV)-DNA measurements that are greater than the sensitivity of the test will also be excluded. Patients with concurrent autoimmune disease
  • Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease.
  • Patients requiring systemic corticosteroids (excluding those given temporarily for testing, prophylactic administration for allergic reactions, or for the relief of swelling associated with radiotherapy) or immunosuppressive agents, or who have received such therapy <14 days prior to study participation;
  • Patients with a history or finding of class ≥III congestive heart failure according to the New York Heart Association functional class;
  • Patients with epilepsy requiring pharmacological treatment;
  • Patients with grade 3 or greater bleeding within 4 weeks prior to enrolment.
  • Patients who have undergone major surgery (open heart or caesarean section, etc.), caesarean biopsy, or trauma within 28 days prior to enrolment. the same day of the week prior to the 4-week period may be enrolled (however, in the case of manual anastomosis without bowel resection, this should be within 14 days prior to enrolment);
  • Patients with non-healing wounds, non-healing ulcers or non-healing fractures.
  • Patients with a history of hypersensitivity reaction to any investigational drug, analogue or excipient.
  • Women who are pregnant or breastfeeding or have the potential to become pregnant.
  • Patients with contraindications to electroacupuncture therapy or patients for whom electroacupuncture is contraindicated in accordance with TCM syndromes.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenwei Hu contact

13912330886

ei1979@163.com

China1 site, 1 recruiting

  • The First People's Hospital of Changzhou

    Changzhou

    +8613912330886, ei1979@163.com

    Recruiting

Other trials in China

About this study

Official title: A Single-Arm, Multicenter Phase II Clinical Study of Regorafenib and Sintilimab in Combination with Electroacupuncture in Patients with MSS Advanced Colorectal Cancer Who Have Failed More Than Second-Line Standard Chemotherapy

The aim of this clinical trial is to find out whether Regorafenib and Sintilimab in combination with electroacupuncture works in treating participants with microsatellite stable (MSS) advanced colorectal cancer who have failed one or more second-line standard chemotherapy regimens. It will also learn about the efficacy and safety of the combination therapy. The main questions the trial aims to answer are:

Does combination therapy reduce the overall survival time ? What medical problems do people have when they take combination therapy?

Read more

Participants will

Regorafenib, take for 2 weeks and stop for 1 week; Sintilimab, intravenous, every 3 weeks; Electroacupuncture was performed 1 day before, on the day of, and on the 2nd day after each cycle of Sintilimab administration, and patients completed 3 treatments in week 1, followed by 1 treatment per week for 2 weeks, with 5 treatments per dosing

Being tested
Regorafenib and Sintilimab in combination with electroacupuncture
Keywords
Regorafenib, Sintilimab, electroacupuncture, colorectal cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Regorafenib and Sintilimab in combination with electroacupunctureDrug

    Regorafenib, take for 2 weeks and stop for 1 week; Sintilimab, intravenous, every 3 weeks; Electroacupuncture was performed 1 day before, on the day of, and on the 2nd day after each cycle of Sintilimab administration, and patients completed 3 treatments in week 1, followed by 1 treatment per week for 2 weeks, with 5 treatments per dosing cycle.

Study groups in NCT06456515
Study groupRoleWhat they receive
Regorafenib and Sintilimab in combination with electroacupunctureExperimentalNot described
Receives: Drug: Regorafenib and Sintilimab in combination with electroacupuncture

What is being measured

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

  1. Overall survival (OS)

    The time from randomization to death

    Measured: Up to 2 years

Secondary outcomes (10)

  1. Objective response rate (ORR)

    The proportion of patients that respond either partially or fully to therapy

    Measured: Up to 2 years

  2. Progression-free survival (PFS)

    The time from randomization until first evidence of disease progression or death

    Measured: Up to 2 years

  3. Disease control rate (DCR)

    Percentage of patients with advanced cancer whose therapeutic intervention has led to a complete response, partial response, or stable disease

    Measured: Up to 2 years

  4. Time to progression (TTP)

    The time from randomization until first evidence of disease progression

    Measured: Up to 2 years

  5. Health-related quality of life (HRQoL)

    Assessment of patient quality of life with respect to health status

    Measured: Up to 2 years

  6. Adverse events (AE)

    Use the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

    Overall incidence of TEAE;

    • Incidence of grade 3 or higher AE;
    • Incidence of SAEs;
    • Incidence of AEs leading to permanent discontinuation;
    • Incidence of AEs leading to medication suspension or dose adjustment.

    Measured: Up to 2 years

  7. Cancer-related fatigue(CRF)

    A distressing, persistent, subjective sense of physical, emotional, and/or cognitive tiredness or exhaustion related to cancer and/or cancer treatment that is not proportional to recent activity and interferes with usual functioning, use the Revised Piper Fatigue Scale (RPFS)

    Measured: Up to 2 years

  8. Biomarker

    Biomarker analysis can be categorized as "non-genetic" (e.g., associated proteins) or "genetically relevant" (e.g., associated RNA or DNA).

    Measured: Up to 2 years

  9. Cmax

    Based on non-compartmental PK evaluation.Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.

    Blood samples should be collected within 2 hours before electroacupuncture administration and 1 to 4 hours after electroacupuncture by weeks 2 and 3, and 2 hours before electroacupuncture in cycles 4-6

    Measured: Up to 2 years

  10. Immune-related adverse event (irAE)

    Measured: Up to 2 years

Timeline

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

  1. First posted13 Jun 2024
  2. Study start1 May 2024
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06456515
Sponsor's protocol ID
F-IRB-SOP-00710
Status last verified
Feb 2025
First submitted
21 May 2024
Last updated
17 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Regorafenib and Sintilimab in combination with electroacupuncture in people with Colorectal Cancer Metastatic, run by The First People's Hospital of Changzhou 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 13 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: looking for participants now, as of the sponsor's last update on 17 Feb 2025. 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.

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?

Contact Wenwei Hu (13912330886, ei1979@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: Up to 2 years). 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 NCT06456515.

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 17 Feb 2025.

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