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Colorectal NeoplasmsPhase 2NCT05292417

Radiotherapy in Combination With Sintilimab，GM-CSF and Fruquintinib in Patients With MSS mCRC

A Phase 2 study testing hypofractionation Radiotherapy, sintilimab and GM-CSF in people with Colorectal Neoplasms, run by The First Affiliated Hospital of Xiamen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the clinical efficacy and safety of hypofractionation radiotherapy combined with sintilimab，GM-CSF and Fruquintinib in Patients With MSS Metastatic Colorectal Carcinoma (mCRC) Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colorectal Neoplasms
What is being tested?
hypofractionation Radiotherapy, sintilimab and GM-CSF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteChina
Study dates
25 Mar 2022to Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Assigned informed consent
  • Age: 18-80 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3
  • Histological or cytological documentation of adenocarcinoma of the colon or rectum MSS metastatic colorectal cancer(CRC) checked by IHC or PCR.
  • Patients must have failed at least two lines of prior treatment
  • Patients must have not previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody or other drug/antibody that acts on T cell costimulation or checkpoint pathways.
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  • Patients must have not previously received Fruquintinib.
  • Life expectancy of at least 3 months
  • At least 1 measurable disease according to Response Evaluation Criteria in Solid --Tumors (RECIST) criteria, version 1.1.is necessary.
  • Controlled hypertension.
  • Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
  • Women of childbearing age must be negative in pregnancy test. Fertile female and male patients agree to use effective contraceptive methods during the study and within 6 months post to the last dose, such as double barrier contraception, condoms, oral or injection contraceptives, intrauterine devices, abstinence, etc. All female patients will be considered fertile unless the female patient has natural menopause or has undergone artificial menopause or sterilization (hysterectomy, bilateral appendage resection).

Who cannot join

  • Patients with MSI-H / dMMR metastatic colorectal cancer(CRC);
  • Uncontrollable malignant pleural effusion, ascites or pericardial effusion (defined as ineffectively controlled by diuresis or puncture drainage judged by investigators);
  • Clinically significant abnormal electrolyte abnormality as judged by investigators;
  • Clinically significant liver disease, including active viral hepatitis [HBsAg and/or HbcAb is positive and HBV (hepatitis B virus) DNA > 10000 copies/ mL or > 2000 IU/mL; HCV (hepatitis C virus) antibody positive and HCV RNA > 1000 copies/ mL], or other active hepatitis, clinically significant moderate to severe cirrhosis;
  • Central nervous system (CNS) metastasis in previous or screening is excluded ,except CNS without clinical symptom or stable period ≥4 weeks after treatment ;
  • Patients with evidence or history of propensity to hemorrhage within 3 months prior to first dosing, regardless of severity(such as melena, hematemesis, hemoptysis, bloody stools）；
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  • History of arterial thrombosis within 6 months; Patients with history of deep vein thrombosis (DVT) are eligible as long as they have received or are receiving appropriate anticoagulation therapy.
  • Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg despite optimal medical management).
  • Radical radiotherapy within 4 weeks prior to first dosing;
  • Patients have dysphagia;
  • History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of the lung function, etc., which may interfere with the detection and treatment of suspected drug-related lung toxicity, except radiation pneumonitis in the radiation treatment area;
  • Confirmed human immunodeficiency virus (HIV) infection or confirmed syphilis; Patients have high risk of bleeding events such as unhealed wounds, ulcers, fractures,or. patients have active ulcer of stomach and duodenum, ulcerative colitis and other digestive tract diseases or unresectable tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation, as judged by investigators;
  • The adverse events due to previous anti-tumor therapy has not recovered to ≤ CTCAE Grade 1, except alopecia and peripheral neurotoxicity with ≤ CTCAE grade 2 caused by platinum chemotherapy;
  • Patients with active infection and still need systemic treatment;
  • Steroids (more than 10 mg/day prednisone or other equivalent hormones) or other immunosuppressive agents for systemic therapy within 4 weeks prior to first dosing, except nasal spray, inhaled or other topical use of steroid (i.e. no more than 10mg/day prednisone or equivalent doses of other corticosteroids);
  • Any live or attenuated live vaccine within 4 weeks prior to first dosing;
  • Major surgeries within 4 weeks prior to first dosing;
  • Any anti-tumor traditional Chinese medicine taken within 2 weeks prior to first dosing;
  • History of allergies to any ingredient of Sintilimab or Fruquintinib or GM-CSF;
  • Participating in other interventional clinical studies within 4 weeks;
  • Female patients with pregnancy or breastfeeding;
  • Urine routines show urine protein≥ ++, or urine protein quantity≥ 1.0 g during 24 hours；
  • 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);
  • Patients with uncontrolled epilepsy, central nervous system disease, or mental disorders whose clinical severity, as determined by the investigator, may prevent the signing of the informed consent or any condition by which investigators judge patients not suitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

Mingquan Cai contact

15395923893

mingquan035@163.com

Xiyi Liao contact

860592-2137252

liaodoctor@163.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361000

    Mingquan Cai, mingquan035@163.com

    Mingquan Cai

    Recruiting

Other trials in China

About this study

Official title: A Trial of Hypofractionation Radiotherapy in Combination With Sintilimab，GM-CSF and Fruquintinib in Patients With MSS Metastatic Colorectal Carcinoma (mCRC)

To evaluate the clinical efficacy and safety of hypofractionation radiotherapy combined with sintilimab，GM-CSF and Fruquintinib in Patients With MSS Metastatic Colorectal Carcinoma (mCRC)

Read the detailed description

Condition or disease:MSS Metastatic Colorectal Carcinoma (mCRC)

Phase:Phase 2

Intervention/treatment:

Radiation: hypofractionation radiotherapy

Drug: sintilimab, GM-CSF , Fruquintinib

Being tested
hypofractionation Radiotherapy, sintilimab, GM-CSF, Fruquintinib
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • hypofractionation RadiotherapyRadiation

    Also called Radiotherapy

    Patients will receive radiation to the target lesion at a dose of 5Gy, 5 fractions a week, or a dose of 8Gy, 3 fractions a week. The course last once or twice depending on the investigator.

  • sintilimabDrug

    Also called IBI308

    200 mg per IV infusion every 21 days until disease progression or participant withdrawal from study or last for two years

  • GM-CSFDrug

    Also called Human Granulocyte

    200µg given 7-14 days(until WBC≥40x109/L), every 21 days until disease progression or participant withdrawal from study or last for two years.

  • FruquintinibDrug

    Also called Elunate

    Fruquintinib will be given 5mg qd for 2 weeks on and 1 week off, Q3W.

Study groups in NCT05292417
Study groupRoleWhat they receive
Experimental GroupExperimentalhypofractionation radiotherapy combined with sintilimab,GM-CSF and Fruquintinib in the third-line or above treatment of MSS Metastatic Colorectal Carcinoma(mCRC)
Receives: Radiation: hypofractionation Radiotherapy; Drug: sintilimab; Drug: GM-CSF; Drug: Fruquintinib

What is being measured

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

  1. Progression-free survival (PFS)

    Defined as the time from the date of the first dose of treatment to the date of the first documentation of disease progression or death, whichever occurs first.

    Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

    Measured: 2 years

Secondary outcomes (5)

  1. Objective response rate

    Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

    Measured: 1 year

  2. Disease Control Rate（DCR）

    Disease Control Rate（DCR）according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

    Measured: 1 year

  3. Duration of Response(DOR)

    Duration of Response(DOR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

    Measured: 1 year

  4. Overall survival (OS)

    Defined as the time from the date of the first dose of treatment until the date of death due to any cause.

    Measured: 2 years

  5. Safety:Percentage of Participants With Adverse Events (AEs)

    Percentage of Participants With Adverse Events (AEs) Number of participants with adverse events occurring up to 30 days after the last administration are evaluated and graded according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE) for Adverse Events, version 5.01

    Measured: Up to 30 days after the last cycle of per-protocol treatment and 90 days after last dose of treatment

Timeline

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

  1. First posted23 Mar 2022
  2. Study start25 Mar 2022
  3. Primary completionMar 2023 (estimated)
  4. Study completionMar 2024 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
71 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05292417
Sponsor's protocol ID
Caimingquan
Status last verified
Mar 2022
First submitted
10 Mar 2022
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing hypofractionation Radiotherapy, sintilimab and GM-CSF in people with Colorectal Neoplasms, run by The First Affiliated Hospital of Xiamen 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 12 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. 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 phase mean?

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?

Results are not available in the source record.

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

Contact Mingquan Cai (15395923893, mingquan035@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 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 NCT05292417.

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 31 Mar 2022.

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