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Colonic NeoplasmsPhase 1/2JSFOLNCT03985891

The Efficacy of JS001 Combined With Chemotherapy in Patients With Locally Advanced Colon Cancer

A Phase 1/2 study testing Anti-PD-1 Monoclonal Antibody JS001 and Chemotherapy in people with Colonic Neoplasms and Chemotherapy Effect, run by Xiangya Hospital of Central South 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Colon cancer is one of the most lethal malignancies, and colorectal cancer ranks the fifth leading cause of tumor-related mortality in China. FOLFOX is the recommended adjuvant/ neoadjuvant treatment for advanced colon cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Colonic Neoplasms, Chemotherapy Effect
What is being tested?
Anti-PD-1 Monoclonal Antibody JS001 and Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
16 Dec 2020to 1 Jun 2026
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Locally advanced colon cancer patients diagnosed by pathologic biopsy，and the patients have defined indications for neoadjuvant chemotherapy by MDT group.
  • Patients may be available to undergo surgery.
  • Patient has at least 1 measurable lesions according to RECIST version 1.1;
  • Males and females aged ≥18 years.
  • ECOG score 0-1; Estimate life ≥1 year.
  • The main organs and bone marrow function are basically normal:
  • Blood test White blood cell count (WBC)≥2000/mm^ 3; Absolute neutrophil count (ANC)≥1000/mm^ 3; Blood platelet count ≥100000/mm^ 3; Hemoglobin ≥9g/d; Serum creatine ≤ 2.0mg/dL; (2) Liver function Serum total bilirubin (TBIL) is within the normal range (normal range specified by the institution; Total bilirubin of Gilbert syndrome <3.0mg/dL); Serum Aspartate Transaminase (AST), serum Alanine Aminotransferase Transaminase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 * upper limit of normal (ULN); International normalized ratio (INR) ≤1.5(or the patient is taking Warfarin for a long time, INR=2-3), and prothrombin time (PTT) ≤ULN (3) Pulmonary function Carbon Monoxide Diffusing Capacity (DLCO) ≥70% predictive OR; DLCO<70% and ≥55% , and the maximal oxygen consumption VO2 max ≥10L/min/Kg (cardiopulmonary assessment) or 6 minute walk experiment ≥500 meters; Patients with DLCO <55% are not included in this study; Pulse oximetry at rest or walking ≥92% (4) Cardiac function Baseline ECG showes no PR interval prolongation or atrioventricular block; 7. Patient and his/her mate must agree to follow instructions for method of contraception for the duration of the study period and within 6 months of the end of the study (eg. Intrauterine device, birth control pills or condoms); Serum or urine pregnancy test is negative within 7days prior to study enrollment and must be non-lactating; 8. Patients voluntarily joined the study, signed informed consent document, and were well compliant and able to be followed up with testers.

Who cannot join

  • Any previous active autoimmune disease (including any history of inflammatory bowel disease), or history of diseases to be treated with systemic steroids or immunosuppressive drugs(except for vitiligo patients）；
  • Use vaccines against infectious diseases (such as flu, chickenpox, etc.) within 4 weeks (28 days) of starting the study treatment;
  • Active systemic infection requiring treatment, positive detection of hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA);
  • A known positive history or positive test result of human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS);
  • Patients with any severe and/or uncontrolled diseases, such as (1)unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmia；Patients with unsatisfactory blood pressure control (systolic blood pressure >140mmHg,diastolic blood pressure>90mmHg); (2) active or uncontrolled severe infection; (3) liver diseases such as cirrhosis, (4) decompensated liver disease, chronic active hepatitis; poor diabetes control (fasting blood glucose (FBG)> 10mmol/L); (5) urinary routine indicates urinary protein>or=++, and confirmed 24-hour urine protein quantitative >1.0g; (6) having a history of psychotropic substance abuse and being unable to quit or have mental disorders;
  • Pevious treatment with any anti-tumor treatment, including but not limited to chemotherapy, radiotherapy, immunotherapy (such as anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibodies or any other antibodies that target the T cell co-regulatory pathway), etc; Tumor-related therapies or online anticancer drugs are currently being used; Anticoagulant is currently in use; Received major surgery in the past 3weeks;
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  • Studies with previous malignancies, unless complete remission is achieved at least 2 years prior to the start of the study and no other treatment (subjects with basal cell carcinoma of skin and carcinoma in situ of cervix will not be excluded from the study);
  • History of previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, symptomatic interstitial lung disease, or evidence of any activepneumonia found on chest CT scans within 4 weeks prior to the first study drug treatment.
  • Immunosuppressive drugs were used within 2weeks prior to the first study drug treatment, excluding topical glucocorticoids, systemic glucocorticoids ≤ 10mg/day of prednisone or equivalent doses of other glucocorticoids;
  • Pregnant or lactating female;
  • Prisoners who are illegally imprisoned or compulsory for non-mental illness or physical (eg infectious disease) illness;
  • Patients with bleeding tendency (such as active gastrointestinal ulcers) or treatment with anticoagulants or vitamin K antagonists such as warfarin, heparin or the like;
  • A history of allergic reactions to the interventions;
  • According to the investigator's judgment, there are serious concomitant diseases that endanger the safety of the patient or affect the patient's completion of the study;
  • 16. Has received a vaccine within 30 days prior to the study.

Trial locations and contacts

1 site in 1 country.

Shan Zeng, Ph.D, MD. contact

(86)-731-84327633

zengshan2000@csu.edu.cn

China1 site, 1 recruiting

  • Shan Zeng

    Changsha, Hunan, 410008

    Shan Zeng, M.D., +8613574838611

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Prospective Clinical Trial of Safety and Efficacy of JS001 Combined With Chemotherapy in Patients With Locally Advanced Colon Cancer (Perioperative Treatment)

Colon cancer is one of the most lethal malignancies, and colorectal cancer ranks the fifth leading cause of tumor-related mortality in China. FOLFOX is the recommended adjuvant/ neoadjuvant treatment for advanced colon cancer. JS001, as the first Chinese produced anti-PD-1 monoclonal antibody, has been approved by CFDA. This study aims to assess the safety and efficacy of JS001 in combination with FOLFOX as adjuvant/neoadjuvant treatment for patients with locally advanced colon cancer.

Read the detailed description

Colon cancer is one of the most lethal malignancies, and colorectal cancer ranks the fifth leading cause of tumor-related mortality in China. FOLFOX is the recommended adjuvant/ neoadjuvant treatment for advanced colon cancer and it can improve the R0 resection rate, as well as reduce recurrence rate, but the overall responding rate is limited. Currently, immune checkpoint blocked (ICB) emerges as a promising approach in early colon cancer. JS001, as the first Chinese produced anti-PD-1 monoclonal antibody, has been approved by CFDA in melanoma. This study was designed as a prospective, randomized, controlled trial. Patients who meet the enrollment criteria will receive FOLFOX (Q2W) and JS001 (3mg/kg, Q2W) or only FOLFOX for neoadjuvant treatment 6 cycles in pre-operation and same treatment after operation, a total of six months. The assessment will be conducted in the 6th week and 13th week from the initiation date in the first cycle. The patients will be followed up for 5 years. The pCR rate, rCR rate, ORR, DFS, OS and Safety will be compared. This study aims to assess the safety and efficacy of JS001 in combination with FOLFOX as adjuvant/ neoadjuvant treatment for patients with locally advanced colon cancer.

Being tested
Anti-PD-1 Monoclonal Antibody JS001, Chemotherapy
Keywords
Colon cancer, PD-1, Chemotherapy
Medical subject headings
Colonic Neoplasms

What participants receive

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

  • Anti-PD-1 Monoclonal Antibody JS001Drug

    Also called Toripalimab

    Anti-PD-1 monoclonal antibody combined with chemotherapy in patients with locally advanced colon cancer (perioperative treatment)

  • ChemotherapyDrug

    Also called Folfox

    Folfox

Study groups in NCT03985891
Study groupRoleWhat they receive
JS001 in combination with FolfoxExperimentalPatients who meet the enrollment criteria will receive Folfox(Oxaliplatin 85mg/m2 iv Day1; Leucovorin 400mg/m2 iv Day1; 5-FU 400mg/m2 iv bolus on Day1, then1200mg/m2/d x 2days(total 2400mg/m2 over 46-48 hours) iv continuous infusion repeat every 2 weeks) in combination with JS001 (3mg/kg, Q2W). Patients will receive 6 cycles treatment in pre-operation and same cycles after operation.
Receives: Drug: Anti-PD-1 Monoclonal Antibody JS001; Drug: Chemotherapy
FolfoxActive comparatorPatients who meet the enrollment criteria will receive Folfox(Oxaliplatin 85mg/m2 iv Day1; Leucovorin 400mg/m2 iv Day1; 5-FU 400mg/m2 iv bolus on Day1, then1200mg/m2/d x 2days(total 2400mg/m2 over 46-48 hours) iv continuous infusion repeat every 2 weeks). Patients need to receive 6 cycles treatment in pre-operation and same cycles after operation.
Receives: Drug: Chemotherapy

What is being measured

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

  1. pCR rate

    Pathologic complete response rate

    Measured: From the initiation date of first cycle to the date of operation, up to 5 months (each cycle is 2 weeks)

  2. rCR rate

    Radiographic complete response rate

    Measured: From the initiation date of first cycle to the date of operation, up to 5 months (each cycle is 2 weeks)

  3. ORR

    Immunotherapy overall response rate

    Measured: From the initiation date of first cycle to the date of operation, up to 5 months (each cycle is 2 weeks)

Secondary outcomes (2)

  1. DFS

    Disease-free survival

    Measured: From the initiation date of first cycle to the date of first documented progression, loss to follow up or death from any causes, whichever came first, up to 5 years (each cycle is 2 weeks)

  2. OS

    Overall survival

    Measured: From the initiation date of first cycle to the date of death from any causes or loss to follow up, whichever came first, up to 5 years (each cycle is 2 weeks)

Timeline

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

  1. First posted14 Jun 2019
  2. Study start16 Dec 2020 (estimated)
  3. Primary completion1 Jun 2025 (estimated)
  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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03985891
Sponsor's protocol ID
JSFOL--CC. V1.0
Acronym
JSFOL
Status last verified
Dec 2020
First submitted
6 Jun 2019
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Anti-PD-1 Monoclonal Antibody JS001 and Chemotherapy in people with Colonic Neoplasms and Chemotherapy Effect, run by Xiangya Hospital of Central South 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 7 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 17 Dec 2020. 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 Shan Zeng, Ph.D, MD. ((86)-731-84327633, zengshan2000@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR rate (time frame: From the initiation date of first cycle to the date of operation, up to 5 months (each cycle is 2 weeks)). The study lists 3 primary outcomes in all. 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 NCT03985891.

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 17 Dec 2020.

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