ImmunotherapyPhase 2NCT05479240
Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer
A Phase 2 study testing Tislelizumab, Capecitabine and oxaliplatin in people with Immunotherapy, run by Fujian Cancer Hospital.
Trial summary
To compare the efficacy of Neoadjuvant Chemoradiotherapy Combined With/without Tislelizumab in the Treatment of Locally Advanced Rectal Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immunotherapy
- What is being tested?
- Tislelizumab, Capecitabine and oxaliplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Aged 18-75, male or female;
- Rectal adenocarcinoma confirmed by histopathology;
- The lower margin of the tumor as assessed by MRI was below peritoneal reflex-and cT3 was associated with one or more risk factors（cT3c-d，cN1-2；MRF+；EMVI+）;
- Patients who are expected to achieve R0 resection;
- Can swallow pills normally;
- ECOG PS 0-1;
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- Have not received any previous anti-tumor therapy for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.;
- Surgical treatment is planned after completion of neoadjuvant therapy;
- No contraindications;
- Fertile female subjects shall have a negative serological pregnancy test within 72 hours prior to the start of trial drug administration and use effective contraceptive methods during the trial and for at least 3 months after the last dose;For male subjects with fertile female partners, effective contraceptive measures should be used during the trial period and for 3 months after the last dose;
Who cannot join
- Have a history of allergy to monoclonal antibody, tirelizumab, capecitabine, oxaliplatin or other platinum drugs;
- Have previously received or are currently receiving any of the following treatments:
- any surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy for the tumor; B) being treated with an immunosuppressive drug or systemic hormone for immunosuppression purposes within 2 weeks prior to initial use of the study drug (dose >10mg/ day of prednisone or equivalent);In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at doses >10mg/ d of prednisone or equivalent are permitted; C) received live attenuated vaccine within 4 weeks prior to initial use of the study drug; D) major surgery or severe trauma within 4 weeks prior to first use of the study drug;
- Have any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy);Patients with complete remission of psoriasis or childhood asthma/allergy who do not require any intervention as adults may be considered for inclusion, but patients requiring medical intervention with bronchodilators may not be included;
- A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;
- There is not a good control of the heart of the clinical symptoms or disease, including but not limited to: such as (1) the NYHA class II or above for heart failure, (2) the unstable angina, myocardial infarction occurred within 1 year (3), (4) have clinical significance on the chamber of sex or ventricular arrhythmias without clinical intervention or poorly controlled clinical intervention;
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- Severe infection (CTCAE > level 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and complications of infection requiring hospitalization;Baseline chest imaging suggests active lung inflammation, signs and symptoms of infection within 14 days prior to initial use of the study drug, or requiring oral or intravenous antibiotic treatment, except for prophylactic use of antibiotics;
- Those who were found to have active pulmonary tuberculosis infection through medical history or CT examination, or had active pulmonary tuberculosis infection history within 1 year before enrollment, or had active pulmonary tuberculosis infection history more than 1 year ago but without formal treatment;
- Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV RNA higher than the detection limit of analysis method);
- Other malignancies diagnosed within 5 years prior to the first use of the study drug, unless malignancies with a low risk of metastasis or death (5-year survival >90%), such as adequately treated basal cell carcinoma of the skin or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, may be considered for inclusion;
- Pregnant or lactating women;
- In the investigator's judgment, there are other factors that may lead to forced termination of the study, such as other serious medical conditions (including mental illness) requiring concurrent treatment, alcoholism, drug abuse, family or social factors, and factors that may affect the safety or compliance of the subjects.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer--Randomized, Open, Multicenter Clinical Study
To compare the efficacy of Neoadjuvant Chemoradiotherapy Combined With/without Tislelizumab in the Treatment of Locally Advanced Rectal Cancer
- Conditions
- Immunotherapy
- Being tested
- Tislelizumab, Capecitabine, oxaliplatin, short-range radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 6 cycles.
CapecitabineDrug
Participants will receive Capecitabine, 1000mg/m2, day 1-14 of every 3 weeks for 6 cycles
oxaliplatinDrug
Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 6 cycles.
short-range radiotherapyRadiation
5*5Gy，d1-d5
| Study group | Role | What they receive |
|---|---|---|
| short-range radiotherapy sequential Tislelizumab combined with chemotherapy | Experimental | Not described Receives: Drug: Tislelizumab; Drug: Capecitabine; Drug: oxaliplatin; Radiation: short-range radiotherapy |
| short-range radiotherapy combined with chemotherapy | Experimental | Not described Receives: Drug: Capecitabine; Drug: oxaliplatin; Radiation: short-range radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate
Pathological examination of resected tissue samples revealed no residual tumor cells.
Measured: 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Sep 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479240
- Sponsor's protocol ID
- TCO trial
- Status last verified
- May 2023
- First submitted
- 26 Jul 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer--Randomized, Open, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT05479240
- Acronym / sponsor ID
- TCO trial
- Conditions
- Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 29 Jul 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.
To compare the efficacy of Neoadjuvant Chemoradiotherapy Combined With/without Tislelizumab in the Treatment of Locally Advanced Rectal Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short-range radiotherapy sequential Tislelizumab combined with chemotherapy | Experimental | Drug: Tislelizumab, Drug: Capecitabine, Drug: oxaliplatin, Radiation: short-range radiotherapy |
| short-range radiotherapy combined with chemotherapy | Experimental | Drug: Capecitabine, Drug: oxaliplatin, Radiation: short-range radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18-75, male or female;
- Rectal adenocarcinoma confirmed by histopathology;
- The lower margin of the tumor as assessed by MRI was below peritoneal reflex-and cT3 was associated with one or more risk factors（cT3c-d，cN1-2；MRF+；EMVI+）;
- Patients who are expected to achieve R0 resection;
- Can swallow pills normally;
Key exclusion criteria (12 listed)
- Have a history of allergy to monoclonal antibody, tirelizumab, capecitabine, oxaliplatin or other platinum drugs;
- Have previously received or are currently receiving any of the following treatments:
- any surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy for the tumor; B) being treated with an immunosuppressive drug or systemic hormone for immunosuppression purposes within 2 weeks prior to initial use of the study drug (dose >10mg/ day of prednisone or equivalent);In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at doses >10mg/ d of prednisone or equivalent are permitted; C) received live attenuated vaccine within 4 weeks prior to initial use of the study drug; D) major surgery or severe trauma within 4 weeks prior to first use of the study drug;
- Have any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy);Patients with complete remission of psoriasis or childhood asthma/allergy who do not require any intervention as adults may be considered for inclusion, but patients requiring medical intervention with bronchodilators may not be included;
- A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;
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 |
|---|---|---|
| TislelizumabParticipants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 6 cycles. | Drug | short-range radiotherapy sequential Tislelizumab combined with chemotherapy |
| CapecitabineParticipants will receive Capecitabine, 1000mg/m2, day 1-14 of every 3 weeks for 6 cycles | Drug | short-range radiotherapy combined with chemotherapy, short-range radiotherapy sequential Tislelizumab combined with chemotherapy |
| oxaliplatinParticipants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 6 cycles. | Drug | short-range radiotherapy combined with chemotherapy, short-range radiotherapy sequential Tislelizumab combined with chemotherapy |
| short-range radiotherapy5*5Gy，d1-d5 | Radiation | short-range radiotherapy combined with chemotherapy, short-range radiotherapy sequential Tislelizumab combined with chemotherapy |
Primary outcome
Pathological complete response rate
Time frame: 4 weeks after surgery
Pathological examination of resected tissue samples revealed no residual tumor cells.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, Capecitabine and oxaliplatin in people with Immunotherapy, run by Fujian Cancer Hospital.
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 10 inclusion and 12 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: opening soon, as of the sponsor's last update on 18 Jun 2023. 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Chun kang, Doctor of Medicine (13509333116 ext. 86, chuck330@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 (time frame: 4 weeks after surgery). 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 18 Jun 2023.