Rectal CancerNCT06504875
Application of PD-1 Monoclonal Antibody in Combination With IL-2 and CapeOX in Organ Preservation Therapy for Ultra-Low Localized Advanced Rectal Cancer
An observational study of Rectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
The objective is to evaluate whether the neoadjuvant combination of PD-1 inhibitor tislelizumab and interleukin-2 (IL-2) can significantly enhance the complete response rate (cCR + local excision pCR) and organ preservation rate in patients with MSS/pMMR locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Tislelizumab, Interleukin-2 and Capecitabine
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2024to 10 Jul 2027
- Phase
- Observational
- 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
Study population: 1. Age ≥18 years and ≤75 years 2. Histologically confirmed adenocarcinoma of the rectum 3. pMMR (proficient mismatch repair) or MSI-L (microsatellite instability-low) or MSS (microsatellite stable) 4. Tumor distance from the anal verge ≤5 cm 5. Clinical stage of cT1-3N1M0 or cT2-3N0M0 6. ECOG performance status score ≤ 1
Who may be able to join
- Age ≥18 years and ≤75 years
- Histologically confirmed adenocarcinoma of the rectum
- pMMR (proficient mismatch repair) or MSI-L (microsatellite instability-low) or MSS (microsatellite stable)
- Tumor distance from the anal verge ≤5 cm
- Clinical stage of cT1-3N1M0 or cT2-3N0M0
- ECOG performance status score ≤ 1
Who cannot join
- Patients with metastatic disease (Stage IV); recurrent colorectal cancer with active bleeding, perforation, or complex conditions requiring urgent surgery; or concurrent non-colorectal cancer malignancies.
- Patients who have previously received systemic anticancer therapy for colorectal cancer; or have been treated with PD-1, PD-L1, or CTLA-4 antibodies.
- Patients with any active autoimmune disease; known or tested positive for Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS); or a history requiring steroid or immunosuppressive drug treatment.
- Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis, and acute pneumonia).
- Patients who experienced any Grade 2 or higher toxicities due to prior treatments (as classified by the Common Terminology Criteria for Adverse Events [CTCAE] version 5), which have not resolved (excluding anemia, alopecia, and skin pigmentation changes); known or suspected history of hypersensitivity to any of the drugs used in the trial.
- Pregnant or breastfeeding women.
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: Application of PD-1 Monoclonal Antibody in Combination With IL-2 and CapeOX in Organ Preservation Therapy for Ultra-Low Localized Advanced Rectal Cancer: A Single-center, Single-arm, Open-label Clinical Study (PICTURE)
The objective is to evaluate whether the neoadjuvant combination of PD-1 inhibitor tislelizumab and interleukin-2 (IL-2) can significantly enhance the complete response rate (cCR + local excision pCR) and organ preservation rate in patients with MSS/pMMR locally advanced rectal cancer.
Read the detailed description
Colorectal cancer (CRC) stands as a prominent global health concern, ranking among the most prevalent malignancies worldwide. Its incidence exhibits striking geographical variations, with higher rates observed in developed countries. Age is a significant risk factor, predominantly affecting individuals aged 50 and above, although a concerning trend of increasing incidence in younger adults has been noted in recent years. There exists a gender disparity, with slightly higher prevalence in males. Notably, lifestyle factors, including dietary choices, sedentary habits, smoking, and obesity, play crucial roles in its etiology. These epidemiological patterns underscore the urgency for implementing effective prevention strategies and advancing early detection methods to mitigate the disease's impact.
In China, nearly two-thirds of colorectal cancer cases are rectal cancers, with approximately half being low rectal cancers. Currently, surgical resection remains the primary curative approach for patients with low rectal cancer. The concept of Total Mesorectal Excision (TME), introduced in 1982, has become the standard surgical procedure for low rectal cancer, focusing on en bloc removal of the rectum along with its mesentery to reduce the local recurrence rate post-surgery. Building upon this, the advent of neoadjuvant chemoradiotherapy, watch-and-wait strategies, targeted therapies, and immunotherapies has shifted the focus of low rectal cancer management from merely increasing R0 resection rates and decreasing local tumor recurrence to encompassing precise imaging-based staging, efficacy assessment, organ function preservation, and quality-of-life improvements.
In colorectal cancer, the PD-1 inhibition pathway plays a central role in regulating immune cell exhaustion. However, monotherapy targeting PD-1 alone shows limited responses in most colorectal cancer patients, suggesting that combinations with other immunostimulatory agents could address this challenge. Several combinatorial approaches have shown promise in animal models and are now being explored in clinical settings. Among these, Interleukin-2 (IL-2) is emerging as a potential candidate to synergize with PD-1 blockade in exerting antitumor effects. Our study aims to explore the synergy of IL-2 combined with a PD-1 inhibitor, seeking to overcome the limitations of single-agent immunotherapy through multifaceted immune modulation. By enhancing immune cell infiltration and disrupting the physical and immunosuppressive barriers of tumors, we aim to augment the efficacy of immunotherapy and increase the organ preservation rate in ultra-low locally advanced rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Tislelizumab, Interleukin-2, Capecitabine, Oxaliplatin
- Keywords
- Tislelizumab, Interleukin-2, MSS/pMMR 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.
TislelizumabDrug
Tislelizumab 200mg ivd D1
Interleukin-2Drug
Interleukin 2 100IU HD,QOD d1-d14
CapecitabineDrug
Capecitabine: 1000mg/m2 bid po, d1-d14
OxaliplatinDrug
Oxaliplatin 130mg/m2 ivd, d1
| Study group | Role | What they receive |
|---|---|---|
| CapeOX+PD-1+IL-2 | Tislelizumab 200mg ivd D1 + Interleukin 2 100IU HD,QOD d1-d14 +CapeOX (Capecitabine: 1000mg/m2 bid po, d1-d14；Oxaliplatin 130mg/m2 ivd, d1) 6 cycles Receives: Drug: Tislelizumab; Drug: Interleukin-2; Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR rate (cCR + local excision pCR)
Complete Response rate," which includes both "complete clinical response" (cCR) and "pathologic complete response after local excision" (pCR)
Measured: 1 years
Secondary outcomes (3)
organ preservation rates
The assessment of how different treatment strategies, determined by the Complete Response (CR) status post-neoadjuvant chemotherapy, affect the anal sphincter preservation in patients with locally advanced low rectal cancer.
Measured: 1 month
Event-Free Survival rates
Event-Free Survival (EFS) is the length of time after treatment during which the patient survives without any events of interest occurring, such as disease progression, recurrence, or death. Therefore, the 1/2/3-year EFS rates refer to the percentages of patients surviving without these events at 1, 2, and 3 years.
Measured: 5 years
Overall Survival rates
Overall Survival (OS) is the most common endpoint in cancer clinical trials, measuring the proportion of patients still alive at specific time points after the start of treatment. Thus, the 1/2/3-year OS rates represent the percentages of patients still alive at 1, 2, and 3 years post-treatment.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start10 Jul 2024 (estimated)
- Primary completion10 Jul 2025 (estimated)
- Study completion10 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504875
- Sponsor's protocol ID
- PICTURE202407
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of PD-1 Monoclonal Antibody in Combination With IL-2 and CapeOX in Organ Preservation Therapy for Ultra-Low Localized Advanced Rectal Cancer: A Single-center, Single-arm, Open-label Clinical Study (PICTURE)
- ClinicalTrials.gov ID
- NCT06504875
- Acronym / sponsor ID
- PICTURE202407
- Conditions
- Rectal Cancer
- Keywords
- Tislelizumab, Interleukin-2, MSS/pMMR rectal cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (estimated)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- 10 Jul 2027 (estimated)
- First posted
- 17 Jul 2024 (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 objective is to evaluate whether the neoadjuvant combination of PD-1 inhibitor tislelizumab and interleukin-2 (IL-2) can significantly enhance the complete response rate (cCR + local excision pCR) and organ preservation rate in patients with MSS/pMMR locally advanced rectal cancer.
Detailed description
Colorectal cancer (CRC) stands as a prominent global health concern, ranking among the most prevalent malignancies worldwide. Its incidence exhibits striking geographical variations, with higher rates observed in developed countries. Age is a significant risk factor, predominantly affecting individuals aged 50 and above, although a concerning trend of increasing incidence in younger adults has been noted in recent years. There exists a gender disparity, with slightly higher prevalence in males. Notably, lifestyle factors, including dietary choices, sedentary habits, smoking, and obesity, play crucial roles in its etiology. These epidemiological patterns underscore the urgency for implementing effective prevention strategies and advancing early detection methods to mitigate the disease's impact.
In China, nearly two-thirds of colorectal cancer cases are rectal cancers, with approximately half being low rectal cancers. Currently, surgical resection remains the primary curative approach for patients with low rectal cancer. The concept of Total Mesorectal Excision (TME), introduced in 1982, has become the standard surgical procedure for low rectal cancer, focusing on en bloc removal of the rectum along with its mesentery to reduce the local recurrence rate post-surgery. Building upon this, the advent of neoadjuvant chemoradiotherapy, watch-and-wait strategies, targeted therapies, and immunotherapies has shifted the focus of low rectal cancer management from merely increasing R0 resection rates and decreasing local tumor recurrence to encompassing precise imaging-based staging, efficacy assessment, organ function preservation, and quality-of-life improvements.
In colorectal cancer, the PD-1 inhibition pathway plays a central role in regulating immune cell exhaustion. However, monotherapy targeting PD-1 alone shows limited responses in most colorectal cancer patients, suggesting that combinations with other immunostimulatory agents could address this challenge. Several combinatorial approaches have shown promise in animal models and are now being explored in clinical settings. Among these, Interleukin-2 (IL-2) is emerging as a potential candidate to synergize with PD-1 blockade in exerting antitumor effects. Our study aims to explore the synergy of IL-2 combined with a PD-1 inhibitor, seeking to overcome the limitations of single-agent immunotherapy through multifaceted immune modulation. By enhancing immune cell infiltration and disrupting the physical and immunosuppressive barriers of tumors, we aim to augment the efficacy of immunotherapy and increase the organ preservation rate in ultra-low locally advanced rectal cancer.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CapeOX+PD-1+IL-2 | – | Drug: Tislelizumab, Drug: Interleukin-2, Drug: Capecitabine, Drug: OxaliplatinTislelizumab 200mg ivd D1 + Interleukin 2 100IU HD,QOD d1-d14 +CapeOX (Capecitabine: 1000mg/m2 bid po, d1-d14；Oxaliplatin 130mg/m2 ivd, d1) 6 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Age ≥18 years and ≤75 years 2. Histologically confirmed adenocarcinoma of the rectum 3. pMMR (proficient mismatch repair) or MSI-L (microsatellite instability-low) or MSS (microsatellite stable) 4. Tumor distance from the anal verge ≤5 cm 5. Clinical stage of cT1-3N1M0 or cT2-3N0M0 6. ECOG performance status score ≤ 1
Key inclusion criteria (6 listed)
- Age ≥18 years and ≤75 years
- Histologically confirmed adenocarcinoma of the rectum
- pMMR (proficient mismatch repair) or MSI-L (microsatellite instability-low) or MSS (microsatellite stable)
- Tumor distance from the anal verge ≤5 cm
- Clinical stage of cT1-3N1M0 or cT2-3N0M0
Key exclusion criteria (6 listed)
- Patients with metastatic disease (Stage IV); recurrent colorectal cancer with active bleeding, perforation, or complex conditions requiring urgent surgery; or concurrent non-colorectal cancer malignancies.
- Patients who have previously received systemic anticancer therapy for colorectal cancer; or have been treated with PD-1, PD-L1, or CTLA-4 antibodies.
- Patients with any active autoimmune disease; known or tested positive for Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS); or a history requiring steroid or immunosuppressive drug treatment.
- Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis, and acute pneumonia).
- Patients who experienced any Grade 2 or higher toxicities due to prior treatments (as classified by the Common Terminology Criteria for Adverse Events [CTCAE] version 5), which have not resolved (excluding anemia, alopecia, and skin pigmentation changes); known or suspected history of hypersensitivity to any of the drugs used in the trial.
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 |
|---|---|---|
| TislelizumabTislelizumab 200mg ivd D1 | Drug | CapeOX+PD-1+IL-2 |
| Interleukin-2Interleukin 2 100IU HD,QOD d1-d14 | Drug | CapeOX+PD-1+IL-2 |
| CapecitabineCapecitabine: 1000mg/m2 bid po, d1-d14 | Drug | CapeOX+PD-1+IL-2 |
| OxaliplatinOxaliplatin 130mg/m2 ivd, d1 | Drug | CapeOX+PD-1+IL-2 |
Primary outcome
CR rate (cCR + local excision pCR)
Time frame: 1 years
Complete Response rate," which includes both "complete clinical response" (cCR) and "pathologic complete response after local excision" (pCR)
3 secondary outcomes
organ preservation rates
Time frame: 1 month
Event-Free Survival rates
Time frame: 5 years
Overall Survival rates
Time frame: 5 year
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 17 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Rectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
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 6 inclusion and 6 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 17 Jul 2024. 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.
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 Yueming Sun (862568306026, sunyueming@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR rate (cCR + local excision pCR) (time frame: 1 years). 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 17 Jul 2024.