Colon CancerPhase 2NCT05335460
To Determine the Efficacy and Safety of Envafolimab Combined With XELOX for Locally Advanced Colon Cancer
A Phase 2 study testing Envafolimab in people with Colon Cancer, run by Fujian Cancer Hospital.
Trial summary
The objective is to investigate the efficacy and safety of Envafolimab combined with XELOX in neoadjuvant therapy for locally advanced colon cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Envafolimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- May 2022to May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of colon adenocarcinoma
- Radiological signs, evaluated by CT, of T4 or Tany N+ (AJCC 8th) 3 No metastatic involvement in other organs (M0). 4 Uncomplicated primary tumor 5 Patients who have not received systemic chemotherapy or other anti-tumor treatment 6 18-75 years； 7 ECOG 0-1； 8 The patient must have adequate organ function and meet the following laboratory test values during the screening period within 7 days before enrolling:
- Absolute neutrophil cell count (ANC) ≥1.5x109/L, platelet ≥75x109/L, hemoglobin ≥90g/L.(in (Patients with no blood transfusion or growth factor support should be given for 7 days prior to blood collection.)
- Serum creatinine ≤1.5× upper normal range (ULN) or estimated creatinine clearance ≥50mL/min, Glutamate aminotransferase and glutamate aminotransferase (AST and ALT)≤3×ULN.
- Total bilirubin ≤1.5×ULN;If there is Gilbert syndrome or if the indirect bilirubin concentration indicates an extrahepatic source of bile The rise of erythrosin is ≤3×ULN.
- Aptt ≤1.5×ULN, and INR or PT≤1.5×ULN. 9 Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment. Immunosuppressive drugs were started or expected to be used during the trial. Inhaled corticosteroids, physiologic replacement doses of glucocorticoids are allowed 10 Sign written informed consent. 11 Expected overall survival ≥3 months 12 A person is operation and compliance with medical treatment
Who cannot join
- Known to be allergic to any study drug
- The patient has a history of autoimmune disease
- Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment.
- The patient has severe active infections
- A person is known to be infected with the immunodeficiency virus (HIV) or known to be HIV-positive 6、Patients Have high blood pressure that cannot be well controlled by antihypertensive medication or any other uncontrolled disease
- 7 pregnant women or Lactating women 8 The patient has mental illness and cannot comply with the study regulations 9 According to the judgment of the researcher, the patient have other factors that may affect the results of the study or cause the study to be terminated, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment. Patients have severe laboratory abnormalities, which will affect the safety of the patient.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Envafolimab Combined With XELOX in Neoadjuvant Therapy for Locally Advanced Colon Cancer，A Prospective, Single Arm, Single Center ǁ Phase Clinical Trial
The objective is to investigate the efficacy and safety of Envafolimab combined with XELOX in neoadjuvant therapy for locally advanced colon cancer
Read the detailed description
According to the 2019 NCCN guidelines, immunocheckpoint inhibitors are recommended for first-line treatment of metastatic colon cancer patients with high microsatellite instability (msi-h) or mismatched gene deletion (dMMR) who are not suitable for intensive treatment, and for all patients with second-line or above msi-h /dMMR treatment.
This study is a single-center, single-arm phase II study, patients received neoadjuvant therapy with Envafolimab combined with XELOX regimen, with one treatment cycle every 3 weeks and after two cycles accept surgery. To determine the pathologic downstage rates at time of radical resection of colon cancer following neoadjuvant treatment.
- Conditions
- Colon Cancer
- Being tested
- Envafolimab
- Keywords
- locally advanced colon cance, Envafolimab
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvafolimabDrug
Also called XELOX( Oxaliplatin 130mg/m2,ivgtt, Q3w capecitabine 1000mg/m2, p.o Q3w)
300mg,sc,d1,Q3W
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab combined with XELOX regimen | Experimental | Envafolimab:300mg,sc,d1,Q3W XELOX( Oxaliplatin 130mg/m2,ivgtt, Q3w capecitabine 1000mg/m2, p.o Q3w) Receives: Drug: Envafolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRG0/1
the rate of Tumor Regression Grading level 0/1
Measured: within 7 days after surgery
Secondary outcomes (2)
R0 resection rate
The tumor was completely removed, and the cutting edge was negative under microscope, without tumor residue
Measured: within 7 days after surgery
ORR
Objective response rate
Measured: within 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study startMay 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335460
- Sponsor's protocol ID
- STEP-EX001
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Envafolimab Combined With XELOX in Neoadjuvant Therapy for Locally Advanced Colon Cancer，A Prospective, Single Arm, Single Center ǁ Phase Clinical Trial
- ClinicalTrials.gov ID
- NCT05335460
- Acronym / sponsor ID
- STEP-EX001
- Conditions
- Colon Cancer
- Keywords
- locally advanced colon cance, Envafolimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- May 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to investigate the efficacy and safety of Envafolimab combined with XELOX in neoadjuvant therapy for locally advanced colon cancer
Detailed description
According to the 2019 NCCN guidelines, immunocheckpoint inhibitors are recommended for first-line treatment of metastatic colon cancer patients with high microsatellite instability (msi-h) or mismatched gene deletion (dMMR) who are not suitable for intensive treatment, and for all patients with second-line or above msi-h /dMMR treatment.
This study is a single-center, single-arm phase II study, patients received neoadjuvant therapy with Envafolimab combined with XELOX regimen, with one treatment cycle every 3 weeks and after two cycles accept surgery. To determine the pathologic downstage rates at time of radical resection of colon cancer following neoadjuvant treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Envafolimab combined with XELOX regimen | Experimental | Drug: EnvafolimabEnvafolimab:300mg,sc,d1,Q3W XELOX( Oxaliplatin 130mg/m2,ivgtt, Q3w capecitabine 1000mg/m2, p.o Q3w) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological confirmation of colon adenocarcinoma
- Radiological signs, evaluated by CT, of T4 or Tany N+ (AJCC 8th) 3 No metastatic involvement in other organs (M0). 4 Uncomplicated primary tumor 5 Patients who have not received systemic chemotherapy or other anti-tumor treatment 6 18-75 years； 7 ECOG 0-1； 8 The patient must have adequate organ function and meet the following laboratory test values during the screening period within 7 days before enrolling:
Key exclusion criteria (6 listed)
- Known to be allergic to any study drug
- The patient has a history of autoimmune disease
- Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment.
- The patient has severe active infections
- A person is known to be infected with the immunodeficiency virus (HIV) or known to be HIV-positive 6、Patients Have high blood pressure that cannot be well controlled by antihypertensive medication or any other uncontrolled disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnvafolimabAlso: XELOX( Oxaliplatin 130mg/m2,ivgtt, Q3w capecitabine 1000mg/m2, p.o Q3w)300mg,sc,d1,Q3W | Drug | Envafolimab combined with XELOX regimen |
Primary outcome
TRG0/1
Time frame: within 7 days after surgery
the rate of Tumor Regression Grading level 0/1
2 secondary outcomes
R0 resection rate
Time frame: within 7 days after surgery
ORR
Time frame: within 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envafolimab in people with Colon Cancer, run by Fujian Cancer Hospital.
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 6 inclusion and 6 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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Zaisheng Ye (13950203076, flyingengel@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRG0/1 (time frame: within 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2022.