Rectal CancerNCT05176964
Chemotherapy and Tislelizumab With Split-course HFRT for Locally Advanced Rectal Cancer
An observational study of Rectal Cancer and Radiation Oncology, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
The question of how to administer adequate chemotherapy and immunotherapy to synchronise hypofraction radiotherapy （HFRT） treatment strategy to maximise the benefits of neoadjuvant therapy for the improved prognosis of patients with locally advanced rectal cancer (LARC).We aimed to study whether chemotherapy and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Cancer, Radiation Oncology
- What is being tested?
- split-course HFRT, CAPOX chemotherapy and Tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2021to 31 Dec 2025
- Phase
- Observational
- 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
Study population: Hosptal in-patients
Who may be able to join
- Treatment-naïve patients with operable locally advanced cancer (LARC, T3-4 and/or N+)
- Pathologically diagnosed as rectal adenocarcinoma
- Male or non-pregnant female
- Age: 18-70 years old
- Hematology examination：I. White blood cell count ≥4×10^9/L;II. Neutrophils ≥1.5×10^9/L;III. Platelet count ≥100×10^9/L;IV. Hemoglobin ≥9g/L
- Blood biochemical examination: total bilirubin, AST, ALT≤2.0×upper limit of normal; creatinine≤1.5×upper limit of normal
- Functional status: ECOG score 0-1 points or KPS score ≥70 points
- Obtain the patient's informed consent
Who cannot join
- Pathologically diagnosed as non-adenocarcinoma
- Age> 70 years old
- Patients with recurrence and distant metastasis
- Have a history of other malignancies
- Have had radiotherapy and/or chemotherapy
- Pregnant or breastfeeding women
Show all 9Show fewer
- Mentally disordered
- Patients with severe heart, liver, and kidney damage
- Non-compliance or the investigator believes that the patient cannot complete the entire trial treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Benhua Xu
About this study
Official title: Combined Chemotherapy and Tislelizumab With Preoperative Split-course Hypofraction Radiotherapy for Locally Advanced Rectal Cancer:Study Protocol of a Prospective, Single-arm Phase II Trial
The question of how to administer adequate chemotherapy and immunotherapy to synchronise hypofraction radiotherapy （HFRT） treatment strategy to maximise the benefits of neoadjuvant therapy for the improved prognosis of patients with locally advanced rectal cancer (LARC).We aimed to study whether chemotherapy and tislelizumab plus split-course HFRT results in better outcomes in LARC patients.
Read the detailed description
Prior to analyzing continuous variables, the statistical normality of the data will be determined. The differences between the main variables will be compared by using the analysis of variance. A comparison of data on categorical variables will be carried out by χ2 tests or Fisher's exact tests. The OS and PFS was estimated using the Kaplan-Meier method. PFS and OS will be compared using the log-rank test. In cases where variables must be adjusted, we will use the proportional hazard Cox regression model. P values for all analyses will be based on using a significance level of 0.05.
- Conditions
- Rectal Cancer, Radiation Oncology
- Being tested
- split-course HFRT, CAPOX chemotherapy, Tislelizumab
- Keywords
- chemotherapy, tislelizumab, split-course hypofraction radiotherapy, locally advanced rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
split-course HFRTRadiation
Also called hypofraction radiotherapy
7Gy/F, d7, q3w, 5 cycles
CAPOX chemotherapyDrug
Also called oxaliplatin and capecitabine
CAPOX chemotherapy will commence on day 1 for each of six cycles: oxaliplatin 130 mg/m^2 intravenous infusion on day 1,followed by capecitabine 1000 mg/m^2 administered orally twice daily on day 1 to 14 of a 21-day cycle.
TislelizumabDrug
Also called immunotherapy
Tislelizumab 200 mg intravenous infusion on day 1 of each 21-day cycle for each of six cycles.
| Study group | Role | What they receive |
|---|---|---|
| HFRT with concurrent chemotherapy and immunotherapy | CAPOX chemotherapy plus tislelizumab treatment plus split-course HFRT Receives: Radiation: split-course HFRT; Drug: CAPOX chemotherapy; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response(pCR)
pCR is defined as no residual tumor in the surgical specimen.
Measured: 1 year
Secondary outcomes (6)
3-year disease-free survival
the time from randomization to disease recurrence or patient death due to disease progression.
Measured: 2 years
local recurrence rate
It's defined as disease-free proximal, distal and circumferential margins.And its progression was defined as an increase in tumor size.
Measured: 3 years
overall survival(OS)
It's defined as the time after the first dose of study therapy to death from any cause.
Measured: 5 years
Sphincter-sparing surgery rate
sphincter-sparing surgery rate
Measured: 1 year
R0 Resection Rate(R0-R)
It's defined as the percentage of patients undergoing resection, defined as a tumour-free resection margin.
Measured: 1 year
predictive biomarkers andquality of life(QoL)
Objective condition index include subjective perception index objective condition index and subjective perception index.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start31 Dec 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benhua Xu, Fujian Medical University Union Hospital
- Investigators
- Benhua Xu, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176964
- Sponsor's protocol ID
- FujianUnionH-HFRT
- Status last verified
- Sep 2023
- First submitted
- 30 Nov 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng R, Wang BS, Li Z, Chi P, Xu B. Combining chemotherapy and tislelizumab with preoperative split-course hypofraction radiotherapy for locally advanced rectal cancer: study protocol of a prospective, single-arm, phase II trial. BMJ Open. 2023 Mar 16;13(3):e066976. doi: 10.1136/bmjopen-2022-066976.
PubMed 36927585
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Chemotherapy and Tislelizumab With Preoperative Split-course Hypofraction Radiotherapy for Locally Advanced Rectal Cancer:Study Protocol of a Prospective, Single-arm Phase II Trial
- ClinicalTrials.gov ID
- NCT05176964
- Acronym / sponsor ID
- FujianUnionH-HFRT
- Conditions
- Rectal Cancer, Radiation Oncology
- Keywords
- chemotherapy, tislelizumab, split-course hypofraction radiotherapy, locally advanced rectal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Jan 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.
The question of how to administer adequate chemotherapy and immunotherapy to synchronise hypofraction radiotherapy （HFRT） treatment strategy to maximise the benefits of neoadjuvant therapy for the improved prognosis of patients with locally advanced rectal cancer (LARC).We aimed to study whether chemotherapy and tislelizumab plus split-course HFRT results in better outcomes in LARC patients.
Detailed description
Prior to analyzing continuous variables, the statistical normality of the data will be determined. The differences between the main variables will be compared by using the analysis of variance. A comparison of data on categorical variables will be carried out by χ2 tests or Fisher's exact tests. The OS and PFS was estimated using the Kaplan-Meier method. PFS and OS will be compared using the log-rank test. In cases where variables must be adjusted, we will use the proportional hazard Cox regression model. P values for all analyses will be based on using a significance level of 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFRT with concurrent chemotherapy and immunotherapy | – | Radiation: split-course HFRT, Drug: CAPOX chemotherapy, Drug: TislelizumabCAPOX chemotherapy plus tislelizumab treatment plus split-course HFRT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hosptal in-patients
Key inclusion criteria (8 listed)
- Treatment-naïve patients with operable locally advanced cancer (LARC, T3-4 and/or N+)
- Pathologically diagnosed as rectal adenocarcinoma
- Male or non-pregnant female
- Age: 18-70 years old
- Hematology examination：I. White blood cell count ≥4×10^9/L;II. Neutrophils ≥1.5×10^9/L;III. Platelet count ≥100×10^9/L;IV. Hemoglobin ≥9g/L
Key exclusion criteria (9 listed)
- Pathologically diagnosed as non-adenocarcinoma
- Age> 70 years old
- Patients with recurrence and distant metastasis
- Have a history of other malignancies
- Have had radiotherapy and/or chemotherapy
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 |
|---|---|---|
| split-course HFRTAlso: hypofraction radiotherapy7Gy/F, d7, q3w, 5 cycles | Radiation | HFRT with concurrent chemotherapy and immunotherapy |
| CAPOX chemotherapyAlso: oxaliplatin and capecitabineCAPOX chemotherapy will commence on day 1 for each of six cycles: oxaliplatin 130 mg/m^2 intravenous infusion on day 1,followed by capecitabine 1000 mg/m^2 administered orally twice daily on day 1 to 14 of a 21-day cycle. | Drug | HFRT with concurrent chemotherapy and immunotherapy |
| TislelizumabAlso: immunotherapyTislelizumab 200 mg intravenous infusion on day 1 of each 21-day cycle for each of six cycles. | Drug | HFRT with concurrent chemotherapy and immunotherapy |
Primary outcome
pathological complete response(pCR)
Time frame: 1 year
pCR is defined as no residual tumor in the surgical specimen.
6 secondary outcomes
3-year disease-free survival
Time frame: 2 years
local recurrence rate
Time frame: 3 years
overall survival(OS)
Time frame: 5 years
Sphincter-sparing surgery rate
Time frame: 1 year
R0 Resection Rate(R0-R)
Time frame: 1 year
predictive biomarkers andquality of life(QoL)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Derived from this study: PubMed 36927585Zheng R, Wang BS, Li Z, Chi P, Xu B. Combining chemotherapy and tislelizumab with preoperative split-course hypofraction radiotherapy for locally advanced rectal cancer: study protocol of a prospective, single-arm, phase II trial. BMJ Open. 2023 Mar 16;13(3):e066976. doi: 10.1136/bmjopen-2022-066976.
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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. This study is not recruiting at the moment.
Benhua Xu principal investigator
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Radiation Oncology, run by Fujian Medical University Union 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 8 inclusion and 9 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 25 Sep 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.
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 Benhua Xu (86+13696884375, benhuaxu@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(pCR) (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 NCT05176964, 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 25 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.