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TislelizumabPhase 1STARS-RC03NCT04906044

Total Neoadjuvant Treatment Plus PD-1 in Mid-Low Locally Advanced Rectal Cancer

A Phase 1 study testing Sintilimab in people with Tislelizumab and Locally Advanced Rectal Cancer, run by The First Hospital of Jilin University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

There have been many high-quality research publications, including the TNT model of short-term radiotherapy combined with consolidation chemotherapy, and the TNT model of three-drug combination with neoadjuvant chemotherapy with higher treatment intensity combined with CRT. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Sintilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
1 Jun 2021to 1 Jun 2026
Phase
Phase 1
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patients and their families are able to understand and are willing to participate in this clinical study, and sign an informed consent form.
  • Age: 18~80 years old, no gender limit;
  • Pathologically diagnosed rectal adenocarcinoma: differentiated into Grade 1-3, that is, high, medium, and poorly differentiated tubular adenocarcinoma;
  • The initial MRI partial phases are: 1) Local intermediate risk: T3c/d or N1-2 (carcinoma nodules) or very low position or EMVI+ or MRF 1-2mm, without external iliac, total iliac, obturator, main abdomen Arterial lymph node metastasis; 2) Local high risk: T4 or MRF+ or lateral lymph node positive.
  • The distance from the lower edge of the tumor is below the reflex of the peritoneum (MRI evaluation);
  • No distant transfer;
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  • ECOG PS score 0-1 within 7 days before the first medication;
  • Hepatitis B Surface Antigen (HBsAg) (-) and Hepatitis B Core Antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be less than 1000 copies/mL or 200 IU/mL before entering the group.
  • HCV antibody (-)
  • The main organ function is normal.
  • No history of pelvic radiotherapy;
  • No history of rectal cancer surgery or chemotherapy;
  • Not accompanied by systemic infections requiring antibiotic treatment;
  • Heart, lung, liver, and kidney functions can tolerate surgery;
  • Others, based on the results of previous medical history, vital signs, physical examination or laboratory examination, the research doctor judges that you are suitable for participating in this clinical study.

Who cannot join

  • Recurrent rectal cancer;
  • The patient cannot tolerate enhanced nuclear magnetic examination;
  • Patients who are planning to undergo or have previously received organ or bone marrow transplantation;
  • Myocardial infarction or poorly controlled arrhythmia (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females) occurred within 6 months before the first medication (QTc interval is calculated by Fridericia formula);
  • Existence of NYHA standard grade III to IV cardiac insufficiency or color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) <50%;
  • Human immunodeficiency virus (HIV) infection;
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  • Suffer from active tuberculosis;
  • Past and present patients with interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc., which may interfere with the detection and treatment of suspected drug-related lung toxicity;
  • There is a known active or suspicious autoimmune disease. Except those who were in a stable state of the disease at the time of enrollment (no need for systemic immunosuppressive therapy);
  • Received treatment with live vaccines within 28 days before the first administration; except for inactivated viral vaccines for seasonal influenza;
  • Patients who need to receive systemic corticosteroids (> 10 mg/day curative dose of prednisone) or other immunosuppressive drugs within 14 days before the first medication or during the study period. However, the following conditions are allowed to enter the group: in the absence of active autoimmune diseases, patients are allowed to use topical or inhaled steroids, or adrenal hormone replacement therapy with a dose ≤ 10 mg/day prednisone curative dose;
  • Any active infection that requires systemic anti-infective treatment occurs within 14 days before the first administration; except for receiving preventive antibiotic treatment (such as preventing urinary tract infection or chronic obstructive pulmonary disease);
  • Have received other antibody/drug treatments against immune checkpoints in the past, such as PD-1, PD-L1, CTLA4, etc.;
  • Known to have a history of severe allergies to any monoclonal antibody or research drug excipients;
  • In the past 5 years, patients have suffered from malignant tumors whose survival rate is significantly lower than the historical data of our rectal cancer survival rate (properly treated basal cell carcinoma, skin squamous cell carcinoma, small kidney cancer, breast cancer, and papillary thyroid carcinoma are not included here. range);
  • The patient has had arterial embolism diseases in the past 6 months, such as angina pectoris, MI, TIA, CVA, etc.;
  • Have received other types of anti-tumor or experimental treatments;
  • The patient is a female during pregnancy or lactation;
  • The patient has other diseases or abnormal mental states, which may affect the patient's participation in this study;
  • There are patients who may increase the risk of participating in research and research medication, or other severe, acute and chronic diseases, who are not suitable for clinical research based on the judgment of the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Hospital of Jilin University

    Changchun, Jilin, 130021

Other trials in China

About this study

Official title: Total Neoadjuvant Treatment Plus PD-1 in Mid-Low Locally Advanced Rectal Cancer (STARS-RC03)

There have been many high-quality research publications, including the TNT model of short-term radiotherapy combined with consolidation chemotherapy, and the TNT model of three-drug combination with neoadjuvant chemotherapy with higher treatment intensity combined with CRT. All have achieved better tumor regression and tumor regression than the standard CRT model. The higher pCR rate reduces the recurrence and metastasis events, improves the prognosis, and strives for more opportunities for organ function preservation. Can the TNT model combined with immunotherapy further increase the cCR rate? Whether immunotherapy can bring further survival benefits to patients who develop CR after neoadjuvant therapy (especially W\&W after cCR), it is also necessary to carry out corresponding clinical research. We designed this study for patients with mid-to-low and locally advanced rectal cancer who want to be able to preserve the anus. TNT mode combined with PD-1 immunotherapy is given before surgery, and TME surgery is performed on patients who have not reached cCR or who still require surgery. It provides sufficient evidence for the safety and effectiveness of preoperative neoadjuvant therapy for PD-1 in low- and middle-level locally advanced rectal cancer.

Being tested
Sintilimab

What participants receive

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

  • SintilimabDrug

    Sintilimab combined withTotal Neoadjuvant Treatment

Study groups in NCT04906044
Study groupRoleWhat they receive
Total Neoadjuvant Treatment combined with SintilimabExperimentalNot described
Receives: Drug: Sintilimab

What is being measured

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

  1. The incidence of serious adverse events

    Any treatment-related grade 3 or higher non-hematological adverse event determined by CTCAE version v 4.03.

    Measured: 1 year

Secondary outcomes (17)

  1. Complete response rate (CR)

    defined as cCR or pCR achieved after neoadjuvant therapy.

    Measured: one week after Last medication

  2. Neoadjuvant colorectal cancer (NAR) score

    NAR score is a continuous scale with 24 possible discrete scores, ranging from 0 to 100. In this patient cohort, low scores were defined as <8, median values were 8-16, and high scores were> 16, and the corresponding 5-year OS was 92%, 89%, and 68%, respectively. A higher score is associated with a worse prognosis.

    Measured: One week after the surgery

  3. Tumor downgrading rate

    the rate of downgrading confirmed by MRI

    Measured: One week after surgery

  4. 3-year non-local regeneration disease-free survival (NR-DFS)

    It is defined as the time of death, local recurrence after radical resection, and any form of distant metastasis within 3 years from the date of receiving neoadjuvant therapy. The local regeneration of the tumor that can be rescued after non-surgical treatment is not regarded as a local recurrence, nor is it counted as a positive event.

    Measured: 3 years from the date of receiving neoadjuvant therapy

  5. 3 years disease-free survival

    3 years disease-free survival

    Measured: 3 years from the date of receiving neoadjuvant therapy

  6. 5 years disease-free survival

    5 years disease-free survival

    Measured: 5 years from the date of receiving neoadjuvant therapy

  7. 3-year local recurrence rate

    3-year local recurrence rate

    Measured: 3 years from the date of receiving neoadjuvant therapy

  8. 3 years overall survival

    3 years overall survival

    Measured: 3 years from the date of receiving neoadjuvant therapy

  9. 5 years overall survival

    5 years overall survival

    Measured: 5 years from the date of receiving neoadjuvant therapy

  10. QLQ-C30 score

    QLQ-C30（Quality of Life Questionnaire C30）

    Measured: up to 12 months

  11. QLQ-C29

    QLQ-C29(Quality of Life Questionnaire C29）

    Measured: up to 12 months

  12. Low Anterior Resection Syndrome

    LARS score（Low Anterior Resection Syndrome Questionnaire）

    Measured: up to 12 months

  13. IPSS score

    IPSS score（International Prostate Symptom Score）

    Measured: up to 12 months

  14. CIPE score

    CIPE （Chinese Index of sexual Function for premature Evaluation,CIPE）score

    Measured: up to 12 months

  15. Quality of life and function assessment

    IIEF-5(international questionnaire of erectile function-5)score

    Measured: up to 12 months

  16. FEFSI-6 score

    FEFSI-6 score

    Measured: up to 12 months

  17. Wexner score

    Wexner incontinence score

    Measured: up to 12 months

Timeline

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

  1. First posted28 May 2021
  2. Study start1 Jun 2021
  3. Primary completion18 Oct 2023
  4. Study completion1 Jun 2026 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04906044
Sponsor's protocol ID
STARS-RC03
Acronym
STARS-RC03
Status last verified
Nov 2023
First submitted
10 May 2021
Last updated
18 Nov 2023
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 1 study testing Sintilimab in people with Tislelizumab and Locally Advanced Rectal Cancer, run by The First Hospital of Jilin 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 15 inclusion and 20 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 18 Nov 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of serious adverse events (time frame: 1 year). 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 NCT04906044.

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 18 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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