Locally Advanced Rectal CarcinomaNCT05645094
Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer
An observational study of Locally Advanced Rectal Carcinoma and MSI-High, run by Fudan University.
Trial summary
This is a single center, prospective, single arm clinical trial to evaluate the efficacy and safety of Envafolimab as a neoadjuvant therapy for resectable and locally advanced dMMR or MSI-H rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Locally Advanced Rectal Carcinoma, MSI-High
- What is being tested?
- Envafolimab
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Jun 2026
- Phase
- Observational
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Resectable locally advanced dMMR or MSI-H rectal cancer.
Who may be able to join
- Subjects volunteer to join the study and could complete the signing of the informed consent form, and had good compliance;
- Age ≥ 18 years old and<80 years old (when signing the informed consent form);
- ECOG score 0-1;
- Resectable rectal cancer was confirmed by pathological diagnosis (pathology/cytology) and imaging;
- The clinical TNM stage is T3-4N0M0 or TanyN+M0;
- The distance from the lower edge of the tumor to the lower edge of the anus is ≤ 10cm;
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- Patients who need routine neoadjuvant therapy after evaluation;
- dMMR or MSI-H was detected by immunohistochemistry/PCR;
- Patients did not received immunotherapy, chemotherapy, targeted therapy or radiotherapy for rectal cancer in the past;
- The expected life span exceeds 3 months;
- It has measurable lesions (according to iRECIST standard, the long diameter of CT scan for non lymph node lesions is ≥ 10 mm, and the short diameter of CT scan for lymph node lesions is ≥ 15 mm);
- The function of main organs is normal, they should meet the following standards:
- Blood routine examination: Absolute Neutrophil Count (ANC) 1.5 × 109/L, Platelet (PLT) ≥ 70 × 109/L, Hemoglobin (HGB) ≥ 90 g/L;
- Liver function: total bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤ 3 × ULN; Serum albumin ≥ 28 g/L; Alkaline phosphatase (ALP) ≤ 5 × ULN; After routine liver protection treatment, it meets the above criteria, and can be stable for at least 1 week. After evaluation by the researcher, it can be included in the group;
- Renal function: serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/mi (using the standard Cockcroft Gault formula);
- Coagulation function: International Normalized Ratio (INR) ≤ 1.5/PT ≤ 1.5 × ULN，aPTT≤1.5 × ULN; If the subject is receiving anticoagulation treatment, PT and INR should be within the scope of anticoagulation drugs.
- Thyroid function: normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is beyond the normal range, the subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group;
- Female patients must be non pregnant and non lactating, and need to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill or condom) during the study treatment period and at least 120 days after the end of the study. During this period, it is not allowed to donate eggs to others or freeze them for fertilization and reproduction.
Who cannot join
- Patients with active autoimmune diseases or autoimmune diseases that may recur are as follows, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, and those who have previously undergone thyroid surgery cannot be included; Subjects who suffer from vitiligo or asthma in childhood has completely alleviated, and do not need any intervention after adulthood can be included; Asthma requiring medical intervention with bronchodilators was excluded;
- Subjects with any severe and/or uncontrollable disease. include:
- Poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
- Suffering from ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470ms) and ≥ grade 2 congestive heart failure (NYHA classification);
- Active or uncontrolled serious infection (≥ CTCAE level 2 infection) requiring systemic anti bacterial, anti fungal or anti-virus treatment, including tuberculosis infection. Active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA ≥ 2000 IU/ml or ≥ 104 copies/ml; hepatitis C reference: HCV RNA ≥ 2000 IU/ml or ≥ 104 copies/ml; after nucleotide antiviral treatment, it is lower than the above criteria, it can be included in the group); Chronic hepatitis B virus carriers, HBV DNA<2000 IU/ml, must receive antiviral treatment at the same time during the trial to be included in the group;
- Renal failure requiring hemodialysis or peritoneal dialysis;
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- Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
- Poor control of diabetes (fasting blood glucose [FBG]>10mmol/L);
- Those who received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the start of the study treatment; Or there is a wound or fracture that has not been cured for a long time;
- Serious arteriovenous thrombotic events occurred within 6 months before the study treatment, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- Those who have a history of abuse of psychotropic substances and are unable to quit or have mental disorders;
- Tumor related symptoms and treatment:
- Within 3 weeks before the start of the study treatment, he had received surgery, chemotherapy, small molecule targeted therapy, radiotherapy or other anti-tumor therapy (washout period is calculated from the end time of the last treatment).
- Within 2 weeks before the start of the study, those who have received the treatment of Chinese patent drugs with anti-tumor indications specified in the NMPA approved drug manual (including compound cantharis capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea javanica oil injection/capsule, Xiaoaiping tablet/injection, cinobufagin capsule, etc.);
- Uncontrolled pleural effusion, pericardial effusion or ascites that still need repeated drainage (judged by the investigator);
- Study treatment related:
- The history of live attenuated vaccine vaccination within 14 days before the start of the study treatment or the plan for live attenuated vaccine vaccination during the study period;
- Severe hypersensitivity reaction occurred after using monoclonal antibody;
- Active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids or immunosuppressants) occurred within 2 years before the start of the study treatment, except for substitution therapy (such as thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiency);
- Diagnosed as immune deficiency or being treated with systemic glucocorticoid or any other form of immunosuppressive therapy. (dosage>10mg/day prednisone or other effective hormones), and continue to use within 2 weeks after the first administration;
- Have a history of active tuberculosis;
- Those who are participating in or have participated in other clinical researches within 4 weeks before the start of the study;
- Have a history of severe allergy;
- Known allergy to the active ingredient or excipient of Envafolimab;
- According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the subject or affect the completion of the study, or subjects who believe that there are other reasons that are not suitable for inclusion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer: a Single-arm, Prospective Trial
This is a single center, prospective, single arm clinical trial to evaluate the efficacy and safety of Envafolimab as a neoadjuvant therapy for resectable and locally advanced dMMR or MSI-H rectal cancer.
- Conditions
- Locally Advanced Rectal Carcinoma, MSI-High
- Being tested
- Envafolimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvafolimabDrug
Patients will receive single drug therapy of Envafolimab (300mg) once every two weeks. Patients who do not have tumor regression after 3 months of treatment should be judged by the investigator whether to adopt standard chemoradiotherapy plus surgery. Patients with tumor regression should continue to receive Envafolimab therapy until 6 months. For patients who do not reach complete clinical response (cCR) after 6 months of treatment, the investigator shall determine whether to perform standard chemoradiotherapy or radical surgery. For patients who reach cCR, they could receive the observation waiting or local resection which depend on the investigator. Patients should be followed up until reaching cCR or 3 years after surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
cCR and pCR rates
Complete clinical response rate (cCR) after neoadjuvant therapy or complete pathological response rate (pCR) of patients undergoing surgery
Measured: 1-year
Secondary outcomes (7)
Tumor regression grade (TRG)
Surgical excision specimens are taken every 1 cm, and the sections are given to at least 2 pathologists for independent scoring
Measured: 1-year
Objective response rate (ORR)
Measured: 1-year
local regrowth rate after cCR
Measured: 3-year
3-year relapse-free survival
relapse-free survival refers to the period of time between the date of surgery and the day of the patient's tumor recurrence or death (earliest occurrence).
Measured: 3-year
3-year overall survival
For patients who still survive when the final analysis takes place, the date of the last 1 contact will be recorded.
Measured: 3-year
Patients' quality of life
The European Organization for Research and Treatment (EORTC)-QLQ-C30 HRQL questionnaire was assessed with repeated measures at regular intervals postoperatively at months 3, 6, 9, 12, 18, and 24
Measured: 3-month, 6-month, 9-month, 12-month, 18-month, 24-month
Acute toxicity associated with Envafolimab
According to the NCI CTCAE v5.0 assessment, the proportion of patients with treatment-related acute toxicity developed from the beginning of treatment to 90 days after the end of Envafolimab
Measured: from the beginning of treatment to 90 days after the end of Envafolimab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI XIN-XIANG, Fudan University
- Investigators
- Xinxiang Li, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645094
- Sponsor's protocol ID
- FDCRC85LXX
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- 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 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer: a Single-arm, Prospective Trial
- ClinicalTrials.gov ID
- NCT05645094
- Acronym / sponsor ID
- FDCRC85LXX
- Conditions
- Locally Advanced Rectal Carcinoma, MSI-High
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 9 Dec 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.
This is a single center, prospective, single arm clinical trial to evaluate the efficacy and safety of Envafolimab as a neoadjuvant therapy for resectable and locally advanced dMMR or MSI-H rectal cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Resectable locally advanced dMMR or MSI-H rectal cancer.
Key inclusion criteria (18 listed)
- Subjects volunteer to join the study and could complete the signing of the informed consent form, and had good compliance;
- Age ≥ 18 years old and<80 years old (when signing the informed consent form);
- ECOG score 0-1;
- Resectable rectal cancer was confirmed by pathological diagnosis (pathology/cytology) and imaging;
- The clinical TNM stage is T3-4N0M0 or TanyN+M0;
Key exclusion criteria (25 listed)
- Patients with active autoimmune diseases or autoimmune diseases that may recur are as follows, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, and those who have previously undergone thyroid surgery cannot be included; Subjects who suffer from vitiligo or asthma in childhood has completely alleviated, and do not need any intervention after adulthood can be included; Asthma requiring medical intervention with bronchodilators was excluded;
- Subjects with any severe and/or uncontrollable disease. include:
- Poor control of diabetes (fasting blood glucose [FBG]>10mmol/L);
- Those who received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the start of the study treatment; Or there is a wound or fracture that has not been cured for a long time;
- Serious arteriovenous thrombotic events occurred within 6 months before the study treatment, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
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 |
|---|---|---|
| EnvafolimabPatients will receive single drug therapy of Envafolimab (300mg) once every two weeks. Patients who do not have tumor regression after 3 months of treatment should be judged by the investigator whether to adopt standard chemoradiotherapy plus surgery. Patients with tumor regression should continue to receive Envafolimab therapy until 6 months. For patients who do not reach complete clinical response (cCR) after 6 months of treatment, the investigator shall determine whether to perform standard chemoradiotherapy or radical surgery. For patients who reach cCR, they could receive the observation waiting or local resection which depend on the investigator. Patients should be followed up until reaching cCR or 3 years after surgery. | Drug | – |
Primary outcome
cCR and pCR rates
Time frame: 1-year
Complete clinical response rate (cCR) after neoadjuvant therapy or complete pathological response rate (pCR) of patients undergoing surgery
7 secondary outcomes
Tumor regression grade (TRG)
Time frame: 1-year
Objective response rate (ORR)
Time frame: 1-year
local regrowth rate after cCR
Time frame: 3-year
3-year relapse-free survival
Time frame: 3-year
3-year overall survival
Time frame: 3-year
Patients' quality of life
Time frame: 3-month, 6-month, 9-month, 12-month, 18-month, 24-month
Acute toxicity associated with Envafolimab
Time frame: from the beginning of treatment to 90 days after the end of Envafolimab
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 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.
Xinxiang Li, MD principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Rectal Carcinoma and MSI-High, run by Fudan 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 18 inclusion and 25 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 13 Dec 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.
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 Yaqi Li, PhD (+8615902194450, yaqili702@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cCR and pCR rates (time frame: 1-year). 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 13 Dec 2022.