Rectal CancerPhase 2NCT06884670
Assessment of Efficacy and Safety of PD-1 Monoclonal Antibody Combined With IL-2 and CapeOX in Neoadjuvant Therapy for Locally Advanced Rectal Cancer Prior to Surgery: A Prospective, Multi-center, Randomized Controlled Study
A Phase 2 study testing Interleukin-2, Radiotherapy and Tislelizumab in people with Rectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 4 sites in China.
Trial summary
The objective is to evaluate whether the neoadjuvant combination of tislelizumab (a PD-1 inhibitor) with interleukin-2 (IL-2) chemotherapy can significantly increase the Objective Response Rate (ORR) and the Pathological Complete Response rate (pCR) in patients with locally advanced rectal cancer who have… 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?
- Interleukin-2, Radiotherapy and Tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 4 sitesChina
- Study dates
- 18 Aug 2024to 1 Jun 2026
- Phase
- Phase 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
- Males and females aged between 18 and 75 years;
- An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Histologically confirmed rectal adenocarcinoma;
- Clinical stage T3-T4 or any T with node-positive (N+) disease: locally advanced;
- Microsatellite stable (MSS) status;
- Adequate hematological, hepatic, and renal functions.
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
4 sites in 1 country.
China4 sites
Nanjing BenQ Hospital
Nanjing, Jiangsu, 210000
Jiangsu province hospital
Nanjing, Jiangsu, 210029
Xuzhou Central hospital
Xuzhou, Jiangsu
The Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu
About this study
Official title: Assessment of Efficacy and Safety of PD-1 Monoclonal Antibody Combined With IL-2 and CapeOX in Neoadjuvant Therapy for Locally Advanced Rectal Cancer Prior to Surgery: A Prospective, Multi-center, Randomized Controlled Study (PICM)
The objective is to evaluate whether the neoadjuvant combination of tislelizumab (a PD-1 inhibitor) with interleukin-2 (IL-2) chemotherapy can significantly increase the Objective Response Rate (ORR) and the Pathological Complete Response rate (pCR) in patients with locally advanced rectal cancer who have Microsatellite Stable/Proficient Mismatch Repair (MSS/pMMR) status.
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 recent years, substantial advancements have reshaped the landscape of CRC treatment, offering new hope and improved outcomes for affected individuals. Surgical intervention remains the cornerstone of curative therapy, guided by tumor stage, location, and patient's overall health status. Adjuvant therapies, including chemotherapy and radiotherapy, have been pivotal in reducing recurrence rates and enhancing overall survival. Targeted treatments, such as anti-EGFR and anti-VEGF drugs, have ushered in an era of precision medicine, selectively targeting critical molecular pathways. Meanwhile, immunotherapy, particularly immune checkpoint inhibitors, has emerged as a promising frontier, offering personalized treatment options for CRC patients.
In CRC, the PD-1 inhibition pathway plays a central role in regulating immune cell exhaustion; however, the response to PD-1 monotherapy is limited in a majority of colorectal cancer patients, suggesting that combining PD-1 blockade with other immunostimulatory agents holds promise. Currently, several combination therapies have shown progress in animal models and are being explored in clinical studies. Among these, interleukin-2 (IL-2) emerges as a candidate drug, synergizing with PD-1 blockade to potentiate antitumor effects. This study aims to investigate the combination of IL-2 with PD-1 inhibitors, seeking to overcome the limitations of single-agent immunotherapy through multifaceted immunomodulation. By modulating the immune microenvironment to enhance immune cell infiltration and break down the physical and immunosuppressive barriers of the tumor, this approach seeks to augment the efficacy of immunotherapy, particularly for immunologically cold CRC patients.
- Conditions
- Rectal Cancer
- Being tested
- Interleukin-2, Radiotherapy, Tislelizumab, Oxaliplatin, Capecitabine
- 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.
Interleukin-2Drug
Tislelizumab 200mg ivd D1+Interleukin 2 100IU HD, d1-d14+ CapeOX (Capecitabine: 825mg/m2 bid po, d1-d14；Oxaliplatin 200 mg/m² ivd, d1)
RadiotherapyRadiation
Radiotherapy 1.8Gy per time*28
TislelizumabDrug
Tislelizumab 200mg ivd D1
OxaliplatinDrug
Oxaliplatin 200 mg/m² ivd, d1
CapecitabineDrug
Capecitabine: 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Conventional Neoadjuvant Group | Active comparator | Patients in the CRT group received long-course radiotherapy to a total dose of 50.4 Gy in 28 fractions of 1.8 Gy, delivered 5 days per week with three-dimensional conformal radiotherapy, VMAT, or IMRT. Concurrent capecitabine was given orally at 825 mg/m² twice daily on days 1-5 each week for 5 weeks. After radiotherapy, patients received four cycles of CapeOX: oxaliplatin 130 mg/m² intravenously on day 1 and capecitabine 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle Receives: Radiation: Radiotherapy; Drug: Oxaliplatin; Drug: Capecitabine |
| PD-1+IL-2+CapeOX group | Experimental | Patients in the PICM group received 21-day cycles of tislelizumab 200 mg intravenously on day 1, oxaliplatin 130 mg/m² intravenously on day 1, capecitabine 1000 mg/m² orally twice daily on days 1-14, and recombinant human IL-2 1 million IU subcutaneously on Monday, Wednesday, and Friday during days 1-14, for six doses per cycle. Rectal MRI was done after two cycles. Patients with tumor regression greater than 20% continued to six cycles; those with regression less than 20%, local progression, or distant metastasis discontinued protocol treatment and received subsequent treatment at the investigator's discretion. Receives: Drug: Interleukin-2; Drug: Tislelizumab; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response rate (pCR)
Measured: 1 year
Clinical complete response (cCR)
Measured: 1 years
near cCR
Measured: 1 years
Secondary outcomes (5)
Safety and Tolerability
Measured: 1 month
Overall survival
3 year Overall survival
Measured: 3 years
Disease free survival (DFS)
3 year DFS
Measured: 3 years
MPR
Major Pathological Response
Measured: 1 year
R0 resection rate
R0 resection rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start18 Aug 2024
- Primary completion31 May 2026
- Study completion1 Jun 2026
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884670
- Sponsor's protocol ID
- PICM
- Status last verified
- Mar 2025
- First submitted
- 11 Jul 2024
- Last updated
- 24 Jun 2026
- 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy and Safety of PD-1 Monoclonal Antibody Combined With IL-2 and CapeOX in Neoadjuvant Therapy for Locally Advanced Rectal Cancer Prior to Surgery: A Prospective, Multi-center, Randomized Controlled Study (PICM)
- ClinicalTrials.gov ID
- NCT06884670
- Acronym / sponsor ID
- PICM
- Conditions
- Rectal Cancer
- Keywords
- Tislelizumab, Interleukin-2, MSS/pMMR rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 18 Aug 2024 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 19 Mar 2025 (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 tislelizumab (a PD-1 inhibitor) with interleukin-2 (IL-2) chemotherapy can significantly increase the Objective Response Rate (ORR) and the Pathological Complete Response rate (pCR) in patients with locally advanced rectal cancer who have Microsatellite Stable/Proficient Mismatch Repair (MSS/pMMR) status.
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 recent years, substantial advancements have reshaped the landscape of CRC treatment, offering new hope and improved outcomes for affected individuals. Surgical intervention remains the cornerstone of curative therapy, guided by tumor stage, location, and patient's overall health status. Adjuvant therapies, including chemotherapy and radiotherapy, have been pivotal in reducing recurrence rates and enhancing overall survival. Targeted treatments, such as anti-EGFR and anti-VEGF drugs, have ushered in an era of precision medicine, selectively targeting critical molecular pathways. Meanwhile, immunotherapy, particularly immune checkpoint inhibitors, has emerged as a promising frontier, offering personalized treatment options for CRC patients.
In CRC, the PD-1 inhibition pathway plays a central role in regulating immune cell exhaustion; however, the response to PD-1 monotherapy is limited in a majority of colorectal cancer patients, suggesting that combining PD-1 blockade with other immunostimulatory agents holds promise. Currently, several combination therapies have shown progress in animal models and are being explored in clinical studies. Among these, interleukin-2 (IL-2) emerges as a candidate drug, synergizing with PD-1 blockade to potentiate antitumor effects. This study aims to investigate the combination of IL-2 with PD-1 inhibitors, seeking to overcome the limitations of single-agent immunotherapy through multifaceted immunomodulation. By modulating the immune microenvironment to enhance immune cell infiltration and break down the physical and immunosuppressive barriers of the tumor, this approach seeks to augment the efficacy of immunotherapy, particularly for immunologically cold CRC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Neoadjuvant Group | Active comparator | Radiation: Radiotherapy, Drug: Oxaliplatin, Drug: CapecitabinePatients in the CRT group received long-course radiotherapy to a total dose of 50.4 Gy in 28 fractions of 1.8 Gy, delivered 5 days per week with three-dimensional conformal radiotherapy, VMAT, or IMRT. Concurrent capecitabine was given orally at 825 mg/m² twice daily on days 1-5 each week for 5 weeks. After radiotherapy, patients received four cycles of CapeOX: oxaliplatin 130 mg/m² intravenously on day 1 and capecitabine 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle |
| PD-1+IL-2+CapeOX group | Experimental | Drug: Interleukin-2, Drug: Tislelizumab, Drug: Oxaliplatin, Drug: CapecitabinePatients in the PICM group received 21-day cycles of tislelizumab 200 mg intravenously on day 1, oxaliplatin 130 mg/m² intravenously on day 1, capecitabine 1000 mg/m² orally twice daily on days 1-14, and recombinant human IL-2 1 million IU subcutaneously on Monday, Wednesday, and Friday during days 1-14, for six doses per cycle. Rectal MRI was done after two cycles. Patients with tumor regression greater than 20% continued to six cycles; those with regression less than 20%, local progression, or distant metastasis discontinued protocol treatment and received subsequent treatment at the investigator's discretion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females aged between 18 and 75 years;
- An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Histologically confirmed rectal adenocarcinoma;
- Clinical stage T3-T4 or any T with node-positive (N+) disease: locally advanced;
- Microsatellite stable (MSS) status;
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 |
|---|---|---|
| Interleukin-2Tislelizumab 200mg ivd D1+Interleukin 2 100IU HD, d1-d14+ CapeOX (Capecitabine: 825mg/m2 bid po, d1-d14；Oxaliplatin 200 mg/m² ivd, d1) | Drug | PD-1+IL-2+CapeOX group |
| RadiotherapyRadiotherapy 1.8Gy per time*28 | Radiation | Conventional Neoadjuvant Group |
| TislelizumabTislelizumab 200mg ivd D1 | Drug | PD-1+IL-2+CapeOX group |
| OxaliplatinOxaliplatin 200 mg/m² ivd, d1 | Drug | Conventional Neoadjuvant Group, PD-1+IL-2+CapeOX group |
| CapecitabineCapecitabine: 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle | Drug | Conventional Neoadjuvant Group, PD-1+IL-2+CapeOX group |
Primary outcome
Pathological Complete Response rate (pCR)
Time frame: 1 year
Clinical complete response (cCR)
Time frame: 1 years
near cCR
Time frame: 1 years
5 secondary outcomes
Safety and Tolerability
Time frame: 1 month
Overall survival
Time frame: 3 years
Disease free survival (DFS)
Time frame: 3 years
MPR
Time frame: 1 year
R0 resection rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interleukin-2, Radiotherapy and Tislelizumab in people with Rectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 4 sites 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 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: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response rate (pCR) (time frame: 1 year). 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?
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 24 Jun 2026.