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Colorectal NeoplasmsPhase 2NCT05551247

Envafolimab Combined With Endostatin in Recurrent or Metastatic MSS-type Colorectal Cancer

A Phase 2 study testing Envafolimab and recombinant human endostatin (endostatin) in people with Colorectal Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The objective is to investigate the efficacy and safety of envafolimab combined with recombinant human endostatin (endostatin) in the treatment of MSS-type colorectal cancer patients with recurrence or metastasis after failure of second-line standard therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Neoplasms
What is being tested?
Envafolimab and recombinant human endostatin (endostatin)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
15 Sep 2022to 28 Jun 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

  • The subjects voluntarily joined the study, signed the informed consent form, and had good compliance;
  • 18-75 years；
  • ECOG 0-1；
  • life expectancy of at least 3 months；
  • Pathological specimens can be provided for biomarker detection
  • Patients with recurrent or metastatic advanced MSS-type colorectal adenocarcinoma diagnosed by pathology and histology, and who are judged by the doctor to be suitable for receiving the nvolimab combined with recombinant human endostatin (endostatin) in this study.
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  • Previously received second-line standard systemic therapy (chemotherapy cycle at least ≥3 cycles), including fluorouracil or its derivatives, oxaliplatin, irinotecan and bevacizumab treatment, disease progression during or after treatment or Relapse, and have not received immune checkpoint inhibitor therapy before; Note: Patients who have received one regimen of adjuvant or neoadjuvant chemotherapy can be enrolled if they relapse > 6 months after the end of chemotherapy;
  • Patients with MSS/pMMR type detected by PCR or IHC in the central laboratory;
  • Patients with at least one measurable lesion according to RECIST 1.1, the efficacy evaluation standard for solid tumors, that is, in CT or MRI detection, the longest diameter of a single lesion is ≥10mm, or the lymph node is pathologically enlarged, and a single lymph node CT scan has a short diameter ≥15mm;
  • Satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥80×109/L, Serum creatinine（CR）≤1.5 upper normal limitation (UNL)，total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; left ventricular ejection fraction (LVEF) ≥ 50%; thyroid stimulating hormone (TSH) within the normal range Within: if the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
  • Subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects

Who cannot join

  • Suffered from other malignant tumors within 3 years before the start of treatment in this study;
  • The pathological indication is mucinous adenocarcinoma and other special pathological types;
  • Grade ≥1 unresolved toxicities (according to the most recent version of the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]) due to any prior therapy, excluding alopecia and fatigue; neurotoxicity was Recovery to ≤ grade 1 or baseline before the group;
  • Subjects with any severe and/or uncontrolled disease ；
  • Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L) ；
  • Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or had a long-term unhealed wound or fracture；
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  • Serious arterial/venous thrombotic event within 6 months prior to initiation of study treatment ；
  • Previously received drug therapy against PD-1, PD-L1 and other related immune checkpoints ；
  • Participating in or participating in other clinical investigators within 4 weeks prior to the start of the study ；
  • Allergic to the active ingredients or excipients of the study drug ；
  • Unsuitable for the study or other chemotherapy determined by investigator.

Trial locations and contacts

No sites are listed yet.

Enxiao Li contact

0086-13992819833

doclienxiao@sina.com

About this study

Official title: A Prospective, Single-arm, Multicenter Clinical Trial of Envafolimab Combined With Recombinant Human Endostatin (Endostatin) in the Treatment of Recurrent or Metastatic MSS-type Colorectal Cancer

The objective is to investigate the efficacy and safety of envafolimab combined with recombinant human endostatin (endostatin) in the treatment of MSS-type colorectal cancer patients with recurrence or metastasis after failure of second-line standard therapy.

Read the detailed description

This study is a multicenter, prospective, single-arm clinical study. That is, eligible colorectal cancer patients, after signing the informed consent form, are screened into the group, and will receive continuous intravenous infusion of envafolimab (envafolimab) combined with recombinant human endostatin (endostatin) until the disease. Progressive or intolerable.

Being tested
Envafolimab, recombinant human endostatin (endostatin)
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

    300mg,sc,d3,Q3W;

  • recombinant human endostatin (endostatin)Drug

    210mg,civ,d1-3,Q3W

Study groups in NCT05551247
Study groupRoleWhat they receive
Envafolimab plus recombinant human endostatin (endostatin)ExperimentalEnvafolimab:300mg,sc,d3,Q3W; endostatin:210mg,civ,d1-3,Q3W.
Receives: Drug: Envafolimab; Drug: recombinant human endostatin (endostatin)

What is being measured

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

  1. ORR

    Objective response rate

    Measured: From Baseline to disease progress, up to 24 months

Secondary outcomes (5)

  1. PFS

    Progression Free Survival

    Measured: From Baseline to primary completion date, about 2 years

  2. OS

    Overall Survival

    Measured: From Baseline to primary completion date, about 2 years

  3. DCR

    Disease Control Rate

    Measured: From Baseline to primary completion date, about 2 years

  4. DOR

    Duration of Response

    Measured: From Baseline to primary completion date, about 2 years

  5. SAE

    severity Adverse Event

    Measured: From Baseline to primary completion date, about 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 posted22 Sep 2022
  2. Study start15 Sep 2022 (estimated)
  3. Primary completion28 Jun 2023 (estimated)
  4. Study completion28 Jun 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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05551247
Sponsor's protocol ID
No.XJTU1AF2022LSK-0076
Status last verified
May 2022
First submitted
31 May 2022
Last updated
22 Sep 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 Envafolimab and recombinant human endostatin (endostatin) in people with Colorectal Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University.

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 11 inclusion and 11 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 22 Sep 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 Enxiao Li (0086-13992819833, doclienxiao@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: From Baseline to disease progress, up to 24 months). 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 NCT05551247.

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 22 Sep 2022.

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