AzTrials
AzTrials

Colorectal CarcinomaPhase 1/2NCT04988191

Toripalimab Plus Bevacizumab and Chemotherapy as Neoadjuvant Therapy in Advanced MSI-H or dMMR Colorectal Cancer

A Phase 1/2 study testing Toripalimab, Bevacizumab and Irinotecan in people with Colorectal Carcinoma, run by Peking 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

This is a trial investigating the efficacy and safety of Toripalimab combined with bevacizumab and chemotherapy as neoadjuvant therapy in patients with advanced microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR) colorectal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Carcinoma
What is being tested?
Toripalimab, Bevacizumab and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
24 Dec 2020to 24 Dec 2023
Phase
Phase 1/2
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

  • Histologically confirmed colorectal adenocarcinoma meeting any of the following criterion: a) T3-4 resectable rectal cancer; b) T1-2 rectal cancer located within 12 cm from the anal verge and refusing direct surgery or radiation therapy; c) T4a-b resectable colon cancer.
  • Microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR).
  • Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and haven't received any local treatment.
  • Eastern Cooperative Oncology Group (ECOG) 0-1.
  • Fully aware of this study and having signed informed consent.
  • Age 18 to 75 years old without gender limitation.
Show all 9Show fewer
  • Good compliance.
  • Absolute neutrophil count ≥1500/mm3, platelet ≥100,000/mm3, Hb ≥10g/dl, serum creatinine ≤1.5 times ULN, creatinine clearance rate ≥50mL/min, ALT and AST ≤2.5 times ULN, INR or aPTT ≤1.5 times ULN (INR ≤2 times ULN and aPTT in normal range for patients who are on prophylactic anticoagulant therapy within 14 days before study treatment), total bilirubin level ≤2 times ULN (within 7 days before study treatment).
  • Women of childbearing age should confirm that serum pregnancy test is negative and agree to use effective contraceptive methods during study treatment and the following 60 days.

Who cannot join

  • Previously received anti-PD1 or anti-PDL1 or anti-PDL2 or anti-CTLA4.
  • Uncontrolled active bleeding from the primary tumor or intestinal obstruction.
  • Contraindications of bevacizumab or irinotecan.
  • Hypersensitivity to other monoclonal antibodies.
  • Any active, known or suspected autoimmune disease.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites to a moderate or greater extent.
Show all 22Show fewer
  • History of one of the following dieases: idiopathic pulmonary fibrosis, organized pneumonia (eg. bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia and interstitial pneumonia, or evidence of active pneumonia through enhanced chest CT screening.
  • Major surgery within 4 weeks before enrollment and haven't fully recovered from the previous surgery.
  • Active bleeding or abnormal coagulation (aPTT >43s or INR >1.5 times ULN), or having a tendency to bleed or receiving thrombolytic or anticoagulant therapy.
  • Previously received allogeneic stem cell or parenchymal organ transplantation.
  • Any significant clinical or laboratory abnormality that the investigator considers to influence the safety assessment, eg. uncontrolled active infection, uncontrolled diabetes, hypertension that cannot be reduced to normal range with monotherapy, grade II or above peripheral neuropathy, congestive heart failure, heart disease (class II or higher) as defined by the New York College of Cardiology, myocardial infarction within 3 months prior to enrollment, unstable arrhythmias, unstable angina pectinis, chronic kidney disease, abnormal thyroid function and previous or co-existing malignancies.
  • History of uncorrected serum electrolyte disturbances such as potassium, calcium and magnesium.
  • HIV infection.
  • Active hepatitis B or hepatitis C.
  • Pregnancy or lactation period, or unwilling to use contraception during the trial.
  • With other malignancy within 5 year, except cervical carcinoma in situ, basal or squamous skin cancer, local prostatic carcinoma and ductal carcinoma in situ.
  • Use corticosteroids (dose of prednisone or similar drugs> 10mg/day) or other immunosuppressive agents within 14 days before enrollment.
  • Patients with active tuberculosis (TB) who are receiving anti-TB treatment or have received anti-TB treatment within 1 year.
  • Active infection, or treatment with oral or intravenous antibiotics within the first 2 weeks prior to neoadjuvant therapy, except prophylactic administration.
  • Anti-infective vaccine (eg. influenza vaccine, varicella vaccine, etc.) injection within 4 weeks before neoadjuvant therapy.
  • Previous participation in other clinical trials within 4 weeks before neoadjuvant therapy.
  • Any other disease, metabolic disorder, abnormal physical examination or abnormal laboratory results that may contrainn the use of trial drug, or affect the reliability of study results, or lead to high risk of treatment complications, or affect patient compliance.

Trial locations and contacts

1 site in 1 country.

Lin Shen, Professor contact

86-10-88196561

linshenpku@163.com

Jian Li, Professor contact

86-10-88196561

oncogene@163.com

China1 site, 1 recruiting

  • Peking University Cancer Hospital and Institute

    Beijing, Beijing Municipality, 100142

    Lin Shen, Professor, 86-10-88196561, Linshenpku@163.com

    Jian Li, Professor, 86-10-88196561, oncogene@163.com

    Recruiting

Other trials in China

About this study

Official title: The Efficacy and Safety of Toripalimab Combined With Bevacizumab and Chemotherapy as Neoadjuvant Therapy in Patients With Advanced MSI-H or dMMR Colorectal Cancer: an Open-label, Multicenter, Single-arm, Phase Ib/II Study

This is a trial investigating the efficacy and safety of Toripalimab combined with bevacizumab and chemotherapy as neoadjuvant therapy in patients with advanced microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR) colorectal cancer.

Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • ToripalimabDrug

    Neoadjuvant therapy: Toripalimab is given by intravenous infusion at 3mg/kg d1 every 2 weeks for 3 cycles.

    Adjuvant therapy: Toripalimab is given by intravenous infusion at a dose of 240mg every 3 weeks for up to 9 cycles.

  • BevacizumabDrug

    Neoadjuvant therapy: Bevacizumab is given by intravenous infusion at 5mg/kg d1 every 2 weeks for 3 cycles.

  • IrinotecanDrug

    Neoadjuvant therapy: Irinotecan is given by intravenous infusion at 180mg/m2 d1 every 2 weeks for 2 cycles.

Study groups in NCT04988191
Study groupRoleWhat they receive
Toripalimab combined with bevacizumab and chemotherapyExperimentalNot described
Receives: Drug: Toripalimab; Drug: Bevacizumab; Drug: Irinotecan

What is being measured

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

  1. Pathological complete response rate based on blinded, independent, central review

    Percentage of patients who achieve pathological complete response (pCR) based on blinded, independent, central review (BICR).

    Measured: 10 weeks

Secondary outcomes (12)

  1. R0 recession rate

    Percentage of patients who achieve R0 recession.

    Measured: 10 weeks

  2. Time to surgery

    Measure of time from study treatment to surgery.

    Measured: 10 weeks

  3. Pathological complete response rate assessed by local investigator

    Percentage of patients who achieve pathological complete response (pCR) based on assessment of local investigator.

    Measured: 10 weeks

  4. Pathological complete response rate based on blinded, independent, central review (BICR) and the assessment of local investigator

    Percentage of patients who achieve pathological complete response (pCR) based on both blinded, independent, central review (BICR) and assessment of local investigator.

    Measured: 10 weeks

  5. Tumor regression grade (TRG)

    Measured: 10 weeks

  6. Objective response rate

    Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).

    Measured: Up to 3 years

  7. Event free survival

    Measure of time from study treatment to disease progression or death.

    Measured: Up to 3 years

  8. Disease-free survival

    Measure of time from the date of surgery to disease relapse or death.

    Measured: Up to 3 years

  9. One-year or two-year disease-free survival rate

    Percentage of patients who achieve disease-free survival lasting for more than one and two years respectively from the date of surgery.

    Measured: Up to 2 years

  10. One-year or two-year overall survival rate

    Percentage of patients who achieve survival for more than one and two years respectively from date of first dose.

    Measured: Up to 2 years

  11. Score of life quality

    Accessment of life quality based on EORTC QLQ-C30 and EORTC QLQ-CR29 scale.

    Measured: Until 30 days after the last treatment

  12. Incidence of Treatment-Related Adverse Events

    Number of adverse events.

    Measured: Until 30 days after the last treatment

Timeline

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

  1. First posted3 Aug 2021
  2. Study start24 Dec 2020
  3. Primary completion24 Jun 2023 (estimated)
  4. Study completion24 Dec 2023 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04988191
Sponsor's protocol ID
JS001-ISS-115
Status last verified
Jul 2021
First submitted
31 Jul 2021
Last updated
3 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang Z, Wang X, Zhang X, Leng J, Cui M, Zhang J, Wang Q, Sun Y, Xu T, Chen M, Li J, Shen L. Toripalimab, bevacizumab, and irinotecan in dMMR/MSI locally advanced colorectal cancer: First-stage results from a phase 1b/2 trial. Cell Rep Med. 2025 Sep 16;6(9):102296. doi: 10.1016/j.xcrm.2025.102296. Epub 2025 Aug 15.

    PubMed 40818457

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Toripalimab, Bevacizumab and Irinotecan in people with Colorectal Carcinoma, run by Peking 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 9 inclusion and 22 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 3 Aug 2021. 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 combined 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.

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 Lin Shen, Professor (86-10-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate based on blinded, independent, central review (time frame: 10 weeks). 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 NCT04988191, which also lists 1 linked publication.

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 3 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in