Gastrointestinal NeoplasmsPhase 2NCT06301828
Endostar Combined With SBRT and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors
A Phase 2 study testing Envafolimab Injection and Endostar in people with Gastrointestinal Neoplasms, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
This is a single-arm, prospective, exploratory clinical study to evaluate the efficacy and safety of endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab in patients with advanced gastrointestinal cancer after multi-line treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Neoplasms
- What is being tested?
- Envafolimab Injection and Endostar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2024to 21 Feb 2026
- 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
- 18 to 75 years old, regardless of gender
- advanced gastrointestinal tumors confirmed by histopathology or cytology;
- patients with gastrointestinal tumors who did not or refused standard treatment at enrollment；Each line of treatment for advanced disease includes one or more drugs for one or more cycles； The pre-permissible treatment was combined with molecular targeted drugs (except endostar)； Patients with previous PD-1 treatment were eligible
- ECOG-PS score of 0-2
- The main organ function was normal and met the following requirements: Blood routine examination (no blood transfusion within 14 days) : a. HB≥80g/L; b. ANC ≥1.5×109/L; c. PLT ≥60×109/L; ② Biochemical examination should meet the following criteria: a. BIL<1.5 times the upper limit of normal (ULN); b. ALT and AST<2.5×ULN; ALT and AST< 5×ULN，if liver metastasis was present; c. Serum Cr≤1×ULN, endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula)
- predicted survival time ≥3 months
- Patients voluntarily participated in this study and signed the informed consent form (ICF)
Who cannot join
- hypertensive patients whose blood pressure could not be reduced to normal range by antihypertensive drugs (systolic blood pressure>140 mmHg/diastolic blood pressure >90 mmHg); Patients with ≥ grade Ⅱ coronary artery disease, arrhythmia (including QTc prolongation > 450 ms in men and > 470 ms in women) and cardiac insufficiency
- patients with active immune diseases
- abnormal coagulation function (INR>1.5×ULN, APTT>1.5×ULN) with bleeding tendency
- symptomatic central nervous system metastasis
- pregnant or lactating women
- Other patients deemed ineligible for enrollment by the treating physician
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
wei x wei, M.D., 52271000 ext. 025
About this study
Official title: A Prospective, Single-arm Clinical Study of Endostar Combined With Stereotactic Body Radiation Therapy and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors After Multi-line Treatment
This is a single-arm, prospective, exploratory clinical study to evaluate the efficacy and safety of endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab in patients with advanced gastrointestinal cancer after multi-line treatment.
Read the detailed description
This is a single-arm, prospective and exploratory clinical study. Sixteen patients with gastric or colorectal cancer who did not have standard treatment or refused standard treatment/chemotherapy after multi-line treatment were enrolled. The patients were treated with endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab to evaluate the efficacy and safety of this regimen. The primary endpoints were objective response rate (ORR) and disease control rate (DCR). The secondary endpoints were safety, progression-free survival (PFS) and overall survival (OS).
- Conditions
- Gastrointestinal Neoplasms
- Being tested
- Envafolimab Injection, Endostar
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envafolimab InjectionDrug
Also called KN035
Endostar+SBRT+Envafolimab Injection
EndostarDrug
Also called Recombinant Human Endostatin Injection
Endostar+SBRT+Envafolimab Injection
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Enrolled patients were treated with endostar combined with stereotactic body radiation therapy and Envafolimab. Receives: Drug: Envafolimab Injection; Drug: Endostar |
What is being measured
The primary outcome is the main question the study is designed to answer.
DCR
The proportion of subjects with complete response (CR), partial response (PR)and stable disease in(SD) in total subjects
Measured: 12 months after the last subject participating in
ORR
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
Measured: 12 months after the last subject participating in
Secondary outcomes (2)
PFS
Progression-free survival (PFS per RECIST 1.1) is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.
Measured: 12 months after the last subject participating in
Incidence of Treatment-Emergent Adverse Events
Occurrence and severity of AEs by NCI CTCAE v5.0
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.
- First posted8 Mar 2024
- Study start21 Feb 2024
- Primary completion21 Jun 2025 (estimated)
- Study completion21 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, 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
- Gastrointestinal neoplasms
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wei X wei, M.D., Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301828
- Sponsor's protocol ID
- KY202401
- Status last verified
- Feb 2024
- First submitted
- 4 Mar 2024
- Last updated
- 8 Mar 2024
- 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 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Clinical Study of Endostar Combined With Stereotactic Body Radiation Therapy and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors After Multi-line Treatment
- ClinicalTrials.gov ID
- NCT06301828
- Acronym / sponsor ID
- KY202401
- Conditions
- Gastrointestinal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 21 Jun 2025 (estimated)
- Study completion
- 21 Feb 2026 (estimated)
- First posted
- 8 Mar 2024 (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.
This is a single-arm, prospective, exploratory clinical study to evaluate the efficacy and safety of endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab in patients with advanced gastrointestinal cancer after multi-line treatment.
Detailed description
This is a single-arm, prospective and exploratory clinical study. Sixteen patients with gastric or colorectal cancer who did not have standard treatment or refused standard treatment/chemotherapy after multi-line treatment were enrolled. The patients were treated with endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab to evaluate the efficacy and safety of this regimen. The primary endpoints were objective response rate (ORR) and disease control rate (DCR). The secondary endpoints were safety, progression-free survival (PFS) and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Gastrointestinal neoplasms
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Envafolimab Injection, Drug: EndostarEnrolled patients were treated with endostar combined with stereotactic body radiation therapy and Envafolimab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 to 75 years old, regardless of gender
- advanced gastrointestinal tumors confirmed by histopathology or cytology;
- patients with gastrointestinal tumors who did not or refused standard treatment at enrollment；Each line of treatment for advanced disease includes one or more drugs for one or more cycles； The pre-permissible treatment was combined with molecular targeted drugs (except endostar)； Patients with previous PD-1 treatment were eligible
- ECOG-PS score of 0-2
- The main organ function was normal and met the following requirements: Blood routine examination (no blood transfusion within 14 days) : a. HB≥80g/L; b. ANC ≥1.5×109/L; c. PLT ≥60×109/L; ② Biochemical examination should meet the following criteria: a. BIL<1.5 times the upper limit of normal (ULN); b. ALT and AST<2.5×ULN; ALT and AST< 5×ULN，if liver metastasis was present; c. Serum Cr≤1×ULN, endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula)
Key exclusion criteria (6 listed)
- hypertensive patients whose blood pressure could not be reduced to normal range by antihypertensive drugs (systolic blood pressure>140 mmHg/diastolic blood pressure >90 mmHg); Patients with ≥ grade Ⅱ coronary artery disease, arrhythmia (including QTc prolongation > 450 ms in men and > 470 ms in women) and cardiac insufficiency
- patients with active immune diseases
- abnormal coagulation function (INR>1.5×ULN, APTT>1.5×ULN) with bleeding tendency
- symptomatic central nervous system metastasis
- pregnant or lactating women
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 |
|---|---|---|
| Envafolimab InjectionAlso: KN035Endostar+SBRT+Envafolimab Injection | Drug | Experimental group |
| EndostarAlso: Recombinant Human Endostatin InjectionEndostar+SBRT+Envafolimab Injection | Drug | Experimental group |
Primary outcome
DCR
Time frame: 12 months after the last subject participating in
The proportion of subjects with complete response (CR), partial response (PR)and stable disease in(SD) in total subjects
ORR
Time frame: 12 months after the last subject participating in
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
2 secondary outcomes
PFS
Time frame: 12 months after the last subject participating in
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- 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.
wei X wei, M.D. study director
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 Injection and Endostar in people with Gastrointestinal Neoplasms, run by Nanjing First Hospital, 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 7 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 8 Mar 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 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 wei x wei, M.D. (52271000 ext. 025, gswxw@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DCR (time frame: 12 months after the last subject participating in). The study lists 2 primary outcomes in all. 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 8 Mar 2024.