Metastatic Colorectal CancerPhase 2NCT06060704
Envafolimab Combined With Trifluridine/Tipiracil and Bevacizumab in the Treatment of Refractory mCRC.
A Phase 2 study testing Envafolimab, Trifluridine/Tipiracil and Bevacizumab in people with Metastatic Colorectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The goal of this single-arm study is to evaluate the efficacy and safety of Envafolimab combined with Trifluridine/Tipiracil and Bevacizumab in the treatment of metastatic colorectal cancer patients who are refractory or intolerant to standard therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Envafolimab, Trifluridine/Tipiracil and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- Nov 2023to Sep 2025
- 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
- Patient able and willing to provide written informed consent and to comply with the study protocol and follow-up inspection.
- Histologically or cytologically documented diagnosis of metastatic colorectal cancer refractory to second-line and above standard treatment; presence of at least one measurable lesions which should be measured on CT or MRI following RECIST 1.1 criteria.
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2.
- Life expectancy of at least 3 months.
- Patient had no serious hematologic,hepatic, or renal abnormalities, and the results within a week were consistent with the following laboratory tests:
- Hematological Parameters: Neutrophil count ≥1.5×109/L;Platelets ≥80×109/L;Hemoglobin≥90g/L.
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- Hepatic Function Parameters: AST and ALT ≤2.5×upper limit of normal（≤5×ULN if liver metastasis present）; Bilirubin ≤2.5 ×upper limit of normal.
- Renal Function Parameters: Cr ≤ 1.5×upper limit of normal.
- Coagulation Function Parameters: International Normalized Ratio (INR)≤1.5 or prothrombin time (PT)≤1.5×ULN or activated partial prothrombin time (APTT)≤1.5×ULN.
- Urinary protein≤1+, 24-hour urinary protein quantity ≤1.0g.
Who cannot join
- Symptomatic or known central nervous system metastases (head CT or MRI is not required to rule out brain metastases). For patients with suspected neurological metastasis, head CT or MRI should be performed within 28 days before enrollment to rule out neurological metastasis.
- The target lesion was treated locally within 3 months.
- There are neurological or psychiatric abnormalities that affect cognitive ability.
- Subjects with hypertension not well controlled by single antihypertensive medication (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg); Patients with history of unstable angina pectoris; Patients with newly diagnosed angina pectoris or myocardial infarction within 3 months prior to screening; Arrhythmias (including QTcF: ≥450 ms in men and ≥470 ms inwomen) require long-term use of antiarrhythmic drugs and New York Heart Association grade ≥II cardiac insufficiency.
- Prior or combined history of other malignancies, with the exception of cured basal cell carcinoma of the skin,carcinoma in situ of the cervix, and other early tumors that are expected to be free of recurrence within six months after radical treatment.
- Patients currently receiving or having received anticancer therapies within 4 weeks prior to the enrollment.
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- For female subjects: should be surgically sterilized, postmenopausal, or consent to use a medically approved contraceptive during the study treatment and for 6 months after the end of the study treatment period; Serum or urine pregnancy tests must be negative within 7days prior to study enrollment and must be non-lactating. Male subjects: Patients who should be surgically sterilized or who have consented to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period.
- There are multiple factors that affect oral medications (such as inability to swallow,chronic diarrhea, and intestinal obstruction).
- Patients with active bleeding, long-term unhealed wounds, and any surgical procedures within 2 months.
- Any arteriovenous thrombosis event occurred within 6 months, including cerebrovascular accident, deep vein thrombosis (deep vein thrombosis caused by the installation of a deep vein catheter in the previous chemotherapy, except for those who were judged to have recovered by the investigator), and pulmonary embolism.
- Severe chest and abdominal fluid, requiring clinical intervention.
- Have thyroid dysfunction that cannot be maintained within the normal range despite medication.
- History of immune deficiency or organ transplantation.
- There were other concomitant diseases that the investigators determined to seriously endanger the patient's safety or interfere with the patient's completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Yanhong Gu, Ph.D, +86 13813908678, guluer@163.com
About this study
Official title: A Prospective, Open, Single-center, Single-arm Study to Explore Envafolimab Combined With Trifluridine/Tipiracil and Bevacizumab in the Treatment of mCRC Patients Who Were Refractory to Second-line and Above Standard Therapy.
The goal of this single-arm study is to evaluate the efficacy and safety of Envafolimab combined with Trifluridine/Tipiracil and Bevacizumab in the treatment of metastatic colorectal cancer patients who are refractory or intolerant to standard therapy.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Envafolimab, Trifluridine/Tipiracil, Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvafolimabDrug
150mg Qw, delivered as a single 1.5ml subcutaneous injection in under 30s , every 4 weeks for one cycle(Q4w).
Trifluridine/TipiracilDrug
Also called TAS-102, FTD/TPI
35 mg/m2 (maximum single dose of 80 mg), po, on days 1-5 and 8-12 of each treatment cycle, twice daily for 28 days, within 1 hour after breakfast or dinner take medicine.
BevacizumabDrug
ivgtt, 5mg/kg, d1, d15, every 4 weeks for one cycle (Q4w). The subjects will receive Trifluridine/Tipiracil plus Bevacizumab and Envafolimab until disease progression, intolerable toxicity, initiation of other anti-tumor therapy, death, withdrawal of informed consent, or loss of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| triplet combination therapy | Experimental | Envafolimab Combined With Trifluridine/Tipiracil and Bevacizumab Receives: Drug: Envafolimab; Drug: Trifluridine/Tipiracil; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR（Objective response rate）
Objective Response Rate defined as the proportion of patients with objective evidence of complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria and using investigator's tumor assessment.
Measured: Approximately 12 months
Secondary outcomes (4)
OS (Overall Survival)
Overall survival defined as the observed time elapsed between the date of first treatment and the date of death due to any cause.
Measured: Approximately 12 months
PFS (Progression-free survival)
Progression-free survival defined as the time elapsed between the randomization and the date of radiologic tumour progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.
Measured: Approximately 12 months
DCR (Disease control rate)
Disease control rate defined as the proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST version 1.1 criteria and using investigator's tumor assessment.
Measured: Approximately 12 months
Quality of life: EORTC QLQ-C30
Assess patients health and activities using the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30) module.
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study startNov 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Model description
- Envafolimab Combined With Trifluridine/Tipiracil and Bevacizumab
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanhong Gu, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060704
- Sponsor's protocol ID
- KEEP-G 09
- Status last verified
- Oct 2023
- First submitted
- 24 Sep 2023
- Last updated
- 11 Oct 2023
- 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 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Single-center, Single-arm Study to Explore Envafolimab Combined With Trifluridine/Tipiracil and Bevacizumab in the Treatment of mCRC Patients Who Were Refractory to Second-line and Above Standard Therapy.
- ClinicalTrials.gov ID
- NCT06060704
- Acronym / sponsor ID
- KEEP-G 09
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 29 Sep 2023 (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 goal of this single-arm study is to evaluate the efficacy and safety of Envafolimab combined with Trifluridine/Tipiracil and Bevacizumab in the treatment of metastatic colorectal cancer patients who are refractory or intolerant to standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Envafolimab Combined With Trifluridine/Tipiracil and Bevacizumab
| Arm | Type | Receives |
|---|---|---|
| triplet combination therapy | Experimental | Drug: Envafolimab, Drug: Trifluridine/Tipiracil, Drug: BevacizumabEnvafolimab Combined With Trifluridine/Tipiracil and Bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient able and willing to provide written informed consent and to comply with the study protocol and follow-up inspection.
- Histologically or cytologically documented diagnosis of metastatic colorectal cancer refractory to second-line and above standard treatment; presence of at least one measurable lesions which should be measured on CT or MRI following RECIST 1.1 criteria.
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2.
- Life expectancy of at least 3 months.
- Patient had no serious hematologic,hepatic, or renal abnormalities, and the results within a week were consistent with the following laboratory tests:
Key exclusion criteria (14 listed)
- Symptomatic or known central nervous system metastases (head CT or MRI is not required to rule out brain metastases). For patients with suspected neurological metastasis, head CT or MRI should be performed within 28 days before enrollment to rule out neurological metastasis.
- The target lesion was treated locally within 3 months.
- There are neurological or psychiatric abnormalities that affect cognitive ability.
- Subjects with hypertension not well controlled by single antihypertensive medication (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg); Patients with history of unstable angina pectoris; Patients with newly diagnosed angina pectoris or myocardial infarction within 3 months prior to screening; Arrhythmias (including QTcF: ≥450 ms in men and ≥470 ms inwomen) require long-term use of antiarrhythmic drugs and New York Heart Association grade ≥II cardiac insufficiency.
- Prior or combined history of other malignancies, with the exception of cured basal cell carcinoma of the skin,carcinoma in situ of the cervix, and other early tumors that are expected to be free of recurrence within six months after radical treatment.
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 |
|---|---|---|
| Envafolimab150mg Qw, delivered as a single 1.5ml subcutaneous injection in under 30s , every 4 weeks for one cycle(Q4w). | Drug | triplet combination therapy |
| Trifluridine/TipiracilAlso: TAS-102, FTD/TPI35 mg/m2 (maximum single dose of 80 mg), po, on days 1-5 and 8-12 of each treatment cycle, twice daily for 28 days, within 1 hour after breakfast or dinner take medicine. | Drug | triplet combination therapy |
| Bevacizumabivgtt, 5mg/kg, d1, d15, every 4 weeks for one cycle (Q4w). The subjects will receive Trifluridine/Tipiracil plus Bevacizumab and Envafolimab until disease progression, intolerable toxicity, initiation of other anti-tumor therapy, death, withdrawal of informed consent, or loss of follow-up. | Drug | triplet combination therapy |
Primary outcome
ORR（Objective response rate）
Time frame: Approximately 12 months
Objective Response Rate defined as the proportion of patients with objective evidence of complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria and using investigator's tumor assessment.
4 secondary outcomes
OS (Overall Survival)
Time frame: Approximately 12 months
PFS (Progression-free survival)
Time frame: Approximately 12 months
DCR (Disease control rate)
Time frame: Approximately 12 months
Quality of life: EORTC QLQ-C30
Time frame: Approximately 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Individual participant dataSharing planned: No
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CRC
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.
Yanhong Gu principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envafolimab, Trifluridine/Tipiracil and Bevacizumab in people with Metastatic Colorectal Cancer, run by The First Affiliated Hospital with Nanjing Medical 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 10 inclusion and 14 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 11 Oct 2023. 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 Yanhong Gu, ph.d (+86 13813908678, guluer@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR（Objective response rate） (time frame: Approximately 12 months). 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 11 Oct 2023.