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Rectal CancerPhase 2RECMULRA-TNTNCT05858567

Total Neoadjuvant Therapy With Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Ultra Low Rectal Adenocarcinoma

A Phase 2 study testing Envafolimab in people with Rectal Cancer, run by Sir Run Run Shaw Hospital at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the total neoadjuvant therapy mode for locally advanced ultra low rectal cancer to preserve the organs. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
Envafolimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
11 May 2023to 30 Jun 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who are willing to receive neoadjuvant therapy.
  • ≧18 years old.
  • Diagnosed by digital rectal examination, colonoscopy, and high-resolution MRI of the pelvis, the tumor is less than or equal to 5 cm from the anus.
  • Histologically diagnosed as rectal adenocarcinoma.
  • The clinical staging by pelvic contrast-enhanced CT and pelvic high-resolution MRI were stage I, II and III.
  • MMR protein detection or MSI gene detection of rectal cancer specimens confirmed pMMR or MSS before treatment .
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  • The patient is difficult cured by anal reserve procedure based on the primary physician's practice.
  • The patient has good compliance and can come to the hospital for re-examination as required.
  • ECOG Scale of Performance Status score 0-1 point.
  • Have not received anti-tumor and immunotherapy before enrollment.
  • Laboratory inspections must meet the following standards:
  • 1) White blood cell count>3.5×109/L, absolute value of neutrophils>1.8×109/L, platelet count ≥75×109/L, hemoglobin ≥100g/L; 2) INR≤1.5, and APTT≤1.5 times the upper limit of normal or partial prothrombin time (PT) ≤1.5 times the upper limit of normal; 3) Total bilirubin ≤ 1.25 times the upper limit of normal; ALT and AST < 5 times the upper limit of normal; 4) 24h creatinine clearance >50mL/min or serum creatinine <1.5 times the upper limit of normal.
  • 12. Voluntarily participate in this study and sign the informed consent.

Who cannot join

  • History of other malignant diseases in the past 5 years.
  • Patients with metastases from other sites (stage IV patients).
  • Patients with positive lateral lymph nodes by pelvic contrast-enhanced CT and pelvic high-resolution MRI.
  • Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery.
  • Known allergic to oxaliplatin, capecitabine, PD-L1 monoclonal antibody and other drugs.
  • Pathologically suggested signet ring cell carcinoma and mucinous adenocarcinoma.
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  • dMMR or MSI-H patients.
  • The patient is accompanied by any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes, hypertension uncontrolled by medication, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial Infarction, congestive heart failure, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease; disease affecting the patient's life.
  • The disease (such as mental illness, etc.) or condition (such as alcoholism or drug abuse, etc.) associated with the patient will increase the risk of the patient receiving the trial drug treatment or affect the patient's compliance with the trial requirements, or may confuse the research results.
  • Active autoimmune disease that may worsen while receiving immunostimulants.
  • Known history of positive HIV test or known acquired immunodeficiency syndrome.
  • Patients who are using immunosuppressive agents, except for the following conditions:
  • 1) Intranasal, inhaled, topical steroids, or topical steroid injections (eg, intra-articular injections); 2) Physiological doses of systemic corticosteroids ≤10 mg/day prednisone or equivalent; 3) Steroids used to prevent allergic reactions (eg, before CT scan). 13. Received any other experimental drug treatment or participated in another interventional clinical trial within 30 days before screening 14. Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeeding during the study period; men or women who are unwilling to take effective contraceptive measures.
  • 15. Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, etc.
  • 16. Other conditions that the investigator judges that the patient is not suitable to participate in the clinical study, etc.

Trial locations and contacts

1 site in 1 country.

sheng dai, MD&PhD contact

13575472669

daimd@zju.edu.cn

China1 site, 1 recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

    Xiujun Cai

    Recruiting

Other trials in China

About this study

Official title: Total Neoadjuvant Therapy With Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Ultra Low Rectal Adenocarcinoma: An Prospective, Single Center, Single Arm Study

Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the total neoadjuvant therapy mode for locally advanced ultra low rectal cancer to preserve the organs. In view of the shortcomings of the current otal neoadjuvant therapy model for locally advanced ultra low rectal cancer, we will explore the feasibility of a new model of short-course radiotherapy combined with immunotherapy, and develop a possible optimal plan based on the existing theoretical basis, namely "short-course radiotherapy + PD-L1 monoclonal antibody combined with CAPEOX chemotherapy for 8 cycles", and explore the efficacy and adverse effects of this model. The study will also attempt to explore the characteristics of the treatment beneficiary population, explore the characteristics of the treatment beneficiary population by multi-dimensional tumor and microenvironmental information through multi-omics sequencing analysis, attempt to build an efficacy prediction model, early screening of the treatment beneficiary population for precise treatment, and thus explore a new model of radiotherapy combined with immunotherapy for the poplation who can be achieved organ preservation.

Conditions
Rectal Cancer
Being tested
Envafolimab
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnvafolimabDrug

    Drug: Envafolimab This product is administered by subcutaneous injection. The recommended dose of subcutaneous injection is 150 mg, administered weekly (QW).

    Other Names:

    KN053 Drug: Oxaliplatin 130mg/m2，ivgtt，d1

    Drug: Capecitabine 1000mg/m2，po，bid，d1-14

    Radiation: Short-course Radiation Short-course radiotherapy, using three-dimensional conformal or intensity-modulated radiotherapy, the dose is divided into 5Gy/f, the total dose is 25Gy/5f, 1f/d, and the irradiation is completed within 7 days.

    Procedure/Surgery: Biopsy, local excision or TME surgery (total mesorectal excision) Biopsy can choose endoscopic or needle biopsy, colcal excision refers to excison of the local lession after total neoadjuvant therapy The total mesorectal excision can choose open, laparoscopic or robotic according to the specific condition of the patient.

Study groups in NCT05858567
Study groupRoleWhat they receive
Total Neoadjuvant Therapy with Short-course Radiation followed by Envafolimab plus CAPEOXExperimentalThe enrolled patients with MSS-type advanced ultra low rectal cancer will receive a combined regimen of neoadjuvant chemoradiotherapy combined with immunotherapy and biopsy or local excision. 1. Radiotherapy uses a short-range mode, irradiating the primary tumor and high-risk areas with dose of 25 Gy. 2. After radiotherapy, PD-L1 antibody (150mg/week, subcutaneous injection × 24 weeks) immunotherapy combined with 8 courses of CAPEOX chemotherapy was performed. 3. Two weeks after the end of the combined treatment plan in step 2), biopsy or local excision of the lesion is performed.
Receives: Drug: Envafolimab

What is being measured

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

  1. Organ reservation rate

    population who achieve complete clinical response after total neoadjuvant therapy

    Measured: After 2 weeks (once biopsy or local excision is done)

Secondary outcomes (8)

  1. Total mesorectal excision rate

    population who not achieve complete clinical response after total neoadjuvant therapy

    Measured: After 2 weeks (once biopsy or local excision is done)

  2. Total mesorectal excision rate after recurrence

    population who recurrent and have Salvage total mesorectal excision after achieving complete clinical response after total neoadjuvant therapy

    Measured: from primary evaluation at 2 weeks after total neoadjuvant therapy finished

  3. Tumor regression grade f

    Tumor regression grade following short-course radiation then Envafolimab Plus CAPEOX as assessed by AJCC/CAP TRG system

    Measured: After 2 weeks (once biopsy or local excision is done)

  4. Overall survival

    The proportion of participants who remain survival at 3 years

    Measured: Up to 3 years

  5. Progression free survival

    The proportion of participants who remain progression free at 3 years

    Measured: Up to 3 years

  6. TRAEs

    Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0

    Measured: Up to 3 years

  7. Surgical Complications

    Surgical Complications of biopsy, local excision or total mesorectal resection procedure for patients after short-course radiation then Envafolimab Plus CAPEOX as assessed by Clavien-Dindo classification

    Measured: Up to 3 years

  8. QoL

    Quality of life of the patients in total neoadjuvant settings of short-course radiation followed with Envafolimab Plus CAPEOX as assessed by Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire liscenced from The Functional Assessment of Chronic Illness Therapy System ("FACIT System"). By using the Manual scoring template, some items are reverse scored. Subscale scores, total scores and TOI scores. The higher the score, the better the QOL.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2023
  2. Study start11 May 2023 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Jun 2025 (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
NCT05858567
Sponsor's protocol ID
SRRSHLS-2023-R0097
Acronym
RECMULRA-TNT
Status last verified
May 2023
First submitted
4 May 2023
Last updated
15 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Envafolimab in people with Rectal Cancer, run by Sir Run Run Shaw Hospital 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 13 inclusion and 15 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 15 May 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 sheng dai, MD&PhD (13575472669, daimd@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Organ reservation rate (time frame: After 2 weeks (once biopsy or local excision is done)). 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 NCT05858567.

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 15 May 2023.

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