Locally Advanced Rectal CancerPhase 2NCT05998122
Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study
A Phase 2 study testing nCRT → (CapeOX+Sintilimab)×6 → Surgery/W&W in people with Locally Advanced Rectal Cancer and Total Neoadjuvant Treatment, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety profile contrasted with 3-cycle counterparts. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer, Total Neoadjuvant Treatment, Anti-PD-1
- What is being tested?
- nCRT → (CapeOX+Sintilimab)×6 → Surgery/W&W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 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
- The patients and their families are able to understand and are willing to participate in this clinical study, and sign an informed consent form.
- Age: 18~75 years old, no gender limit;
- Pathologically diagnosed rectal adenocarcinoma: differentiated into Grade 1-3, that is, high, medium, and poorly differentiated tubular adenocarcinoma; classified as pMMR/MSS.
- The initial TNM risk category (from Rectal cancer: ESMO Clinical Practice Guidelines, 2017 edition) is as follows: 1) "Bad": cT3c/d or very low localisation levators threatened, MRF clear; cT3c/d mid-rectum, cN1-N2 (extranodal), EMVI+, limited cT4aN0; 2) "Advanced": cT3 with any MRF involved, any cT4a/b, lateral node+.
- The lower edge of the tumor is located below the peritoneal reflex;
- No distant transfer;
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- ECOG PS score 0-1 within 7 days before the first medication;
- Hepatitis B Surface Antigen (HBsAg) (-) and Hepatitis B Core Antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be less than 1000 copies/mL or 200 IU/mL before entering the group.
- HCV antibody (-)
- The main organ function is normal.
- No history of pelvic radiotherapy;
- No history of rectal cancer surgery or chemotherapy;
- Not accompanied by systemic infections requiring antibiotic treatment;
- Heart, lung, liver, and kidney functions can tolerate surgery;
- Others, based on the results of previous medical history, vital signs, physical examination or laboratory examination, the research doctor judges that you are suitable for participating in this clinical study.
Who cannot join
- Recurrent rectal cancer;
- Patients who are planning to undergo or have previously received organ or bone marrow transplantation;
- Myocardial infarction or poorly controlled arrhythmia (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females) occurred within 6 months before the first medication (QTc interval is calculated by Fridericia formula);
- Existence of NYHA standard grade III to IV cardiac insufficiency or color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) <50%;
- Human immunodeficiency virus (HIV) infection;
- Suffer from active tuberculosis;
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- Past and present patients with interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc., which may interfere with the detection and treatment of suspected drug-related lung toxicity;
- Patients with active or suspicious autoimmune disease, or with a history of that;
- Received treatment with live vaccines within 28 days before the first administration; except for inactivated viral vaccines for seasonal influenza;
- Have received other antibody/drug treatments against immune checkpoints in the past, such as PD-1, PD-L1, CTLA4, etc.;
- Known to have a history of severe allergies to any monoclonal antibody or research drug excipients;
- In the past 5 years, patients have suffered from malignant tumors whose survival rate is significantly lower than the historical data of our rectal cancer survival rate (properly treated basal cell carcinoma, skin squamous cell carcinoma, small kidney cancer, breast cancer, and papillary thyroid carcinoma are not included here. range);
- The patient has had arterial embolism diseases in the past 6 months, such as angina pectoris, MI, TIA, CVA, etc.;
- Have received other types of anti-tumor or experimental treatments;
- The patient is a female during pregnancy or lactation;
- The patient has other diseases or abnormal mental states, which may affect the patient's participation in this study;
- There are patients who may increase the risk of participating in research and research medication, or other severe, acute and chronic diseases, who are not suitable for clinical research based on the judgment of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
PengYu Chang, Prof. contact
About this study
Official title: Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal High-Risk or Very High-Risk Patients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study
Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety profile contrasted with 3-cycle counterparts. Herein, we designed this study to further evaluate the short-term efficacy (such as pCR rate, R0 resection rate, etc.) and long-term survival (including DFS, OS, etc.) of 6-cycles consolidation therapy.
Read the detailed description
The combination of total neoadjuvant treatment (TNT) and immunotherapy has shown a significant improvement in the pCR rate compared to the standard of care (SOC) or TNT alone for pMMR LARC. On this basis, we believe that this treatment mode will offers the opportunity of organ preservation for subperitoneal "Bad" or "Advanced" patients with LARC, who are initially assessed as unresectable or difficult to obtain R0 resection. Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety profile contrasted with 3-cycle counterparts. Herein, we designed this study to further evaluate the short-term efficacy (such as pCR rate, R0 resection rate, etc.) and long-term survival (including DFS, OS, etc.) of 6-cycles consolidation therapy.
- Being tested
- nCRT → (CapeOX+Sintilimab)×6 → Surgery/W&W
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCRT → (CapeOX+Sintilimab)×6 → Surgery/W&WOther
Radiation: Long-course chemoradiotherapy is delivered in 50 Gy/25 fractions with concurrent Capecitabine (825mg/m2, P.O. Bid, 5d/w).
Drug: CapeOX (Capecitabine 1000mg/m2, P.O. Bid, d1-d14, q3w; Oxaliplatin 130mg/m2, i.v., d1, q3w), and Sintilimab (200mg, i.v. , d1).
Surgical Approach: TME surgery, The surgical approach can be open, laparoscopic or robotic depending on the patient.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Radiation: Long-course chemoradiotherapy is delivered in 50 Gy/25 fractions with concurrent Capecitabine (825mg/m2, P.O. Bid, 5d/w).
Drug: CapeOX (Capecitabine 1000mg/m2, P.O. Bid, d1-d14, q3w; Oxaliplatin 130mg/m2, i.v., d1, q3w), and Sintilimab (200mg, i.v. , d1).
Surgical Approach: TME surgery, The surgical approach can be open, laparoscopic or robotic depending on the patient. Receives: Other: nCRT → (CapeOX+Sintilimab)×6 → Surgery/W&W |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate (CR)
defined as clinical complete response (cCR) or pathologic complete response (pCR) achieved after neoadjuvant therapy.
Measured: Within one week after Last treatment
Secondary outcomes (12)
Disease-Free Survival (DFS)
1/2/3 years disease-free survival
Measured: 1/2/3 years from the date of receiving neoadjuvant therapy
Recurrence -Free Survival (RFS)
1/2/3 years recurrence -free survival
Measured: 1/2/3 years from the date of receiving neoadjuvant therapy
Overall Survival (OS)
3 years overall survival
Measured: 3 years from the date of receiving neoadjuvant therapy
Local Recurrence (LR) Rate
2-year local recurrence rate
Measured: 2 years from the date of receiving neoadjuvant therapy
Organ preservation rate
Organ preservation rate
Measured: 1/2/3 years from the date of receiving neoadjuvant therapy
R0 Resection rate
R0 Resection rate
Measured: Within one week after surgery
The incidence of serious adverse events
Any treatment-related grade 3 or higher non-hematological adverse event determined by CTCAE version v 5.0.
Measured: Within 3 months after Last medication
QLQ-C30 score
Quality of Life Questionnaire C30
Measured: up to 12 months
QLQ-C29 score
Quality of Life Questionnaire C29
Measured: up to 12 months
Low Anterior Resection Syndrome (LARS)
Low Anterior Resection Syndrome Questionnaire
Measured: up to 12 months
Quality of life and function assessment
IIEF-5 (international questionnaire of erectile function-5)score
Measured: up to 12 months
Wexner score
Wexner incontinence score
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (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 Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998122
- Sponsor's protocol ID
- STARS-RC06
- Status last verified
- Aug 2023
- First submitted
- 11 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gu M, Guo Y, He L, Sun X, Liang T, Wang Z, Li Y, Liu Z, Wang J, Qiu X, Guo L, Chang P, Wang Q. Total neoadjuvant chemoradiotherapy plus anti PD-1 for mid-to-low locally advanced rectal cancer: study protocol of a prospective, single arm, phase II study (STARS - RC06). Front Oncol. 2025 Aug 8;15:1594927. doi: 10.3389/fonc.2025.1594927. eCollection 2025.
PubMed 40860797
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal High-Risk or Very High-Risk Patients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study
- ClinicalTrials.gov ID
- NCT05998122
- Acronym / sponsor ID
- STARS-RC06
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Aug 2023 (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.
Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety profile contrasted with 3-cycle counterparts. Herein, we designed this study to further evaluate the short-term efficacy (such as pCR rate, R0 resection rate, etc.) and long-term survival (including DFS, OS, etc.) of 6-cycles consolidation therapy.
Detailed description
The combination of total neoadjuvant treatment (TNT) and immunotherapy has shown a significant improvement in the pCR rate compared to the standard of care (SOC) or TNT alone for pMMR LARC. On this basis, we believe that this treatment mode will offers the opportunity of organ preservation for subperitoneal "Bad" or "Advanced" patients with LARC, who are initially assessed as unresectable or difficult to obtain R0 resection. Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety profile contrasted with 3-cycle counterparts. Herein, we designed this study to further evaluate the short-term efficacy (such as pCR rate, R0 resection rate, etc.) and long-term survival (including DFS, OS, etc.) of 6-cycles consolidation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: nCRT → (CapeOX+Sintilimab)×6 → Surgery/W&WRadiation: Long-course chemoradiotherapy is delivered in 50 Gy/25 fractions with concurrent Capecitabine (825mg/m2, P.O. Bid, 5d/w). Drug: CapeOX (Capecitabine 1000mg/m2, P.O. Bid, d1-d14, q3w; Oxaliplatin 130mg/m2, i.v., d1, q3w), and Sintilimab (200mg, i.v. , d1). Surgical Approach: TME surgery, The surgical approach can be open, laparoscopic or robotic depending on the patient. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The patients and their families are able to understand and are willing to participate in this clinical study, and sign an informed consent form.
- Age: 18~75 years old, no gender limit;
- Pathologically diagnosed rectal adenocarcinoma: differentiated into Grade 1-3, that is, high, medium, and poorly differentiated tubular adenocarcinoma; classified as pMMR/MSS.
- The initial TNM risk category (from Rectal cancer: ESMO Clinical Practice Guidelines, 2017 edition) is as follows: 1) "Bad": cT3c/d or very low localisation levators threatened, MRF clear; cT3c/d mid-rectum, cN1-N2 (extranodal), EMVI+, limited cT4aN0; 2) "Advanced": cT3 with any MRF involved, any cT4a/b, lateral node+.
- The lower edge of the tumor is located below the peritoneal reflex;
Key exclusion criteria (17 listed)
- Recurrent rectal cancer;
- Patients who are planning to undergo or have previously received organ or bone marrow transplantation;
- Myocardial infarction or poorly controlled arrhythmia (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females) occurred within 6 months before the first medication (QTc interval is calculated by Fridericia formula);
- Existence of NYHA standard grade III to IV cardiac insufficiency or color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) <50%;
- Human immunodeficiency virus (HIV) infection;
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 |
|---|---|---|
| nCRT → (CapeOX+Sintilimab)×6 → Surgery/W&WRadiation: Long-course chemoradiotherapy is delivered in 50 Gy/25 fractions with concurrent Capecitabine (825mg/m2, P.O. Bid, 5d/w). Drug: CapeOX (Capecitabine 1000mg/m2, P.O. Bid, d1-d14, q3w; Oxaliplatin 130mg/m2, i.v., d1, q3w), and Sintilimab (200mg, i.v. , d1). Surgical Approach: TME surgery, The surgical approach can be open, laparoscopic or robotic depending on the patient. | Other | Experimental |
Primary outcome
Complete response rate (CR)
Time frame: Within one week after Last treatment
defined as clinical complete response (cCR) or pathologic complete response (pCR) achieved after neoadjuvant therapy.
12 secondary outcomes
Disease-Free Survival (DFS)
Time frame: 1/2/3 years from the date of receiving neoadjuvant therapy
Recurrence -Free Survival (RFS)
Time frame: 1/2/3 years from the date of receiving neoadjuvant therapy
Overall Survival (OS)
Time frame: 3 years from the date of receiving neoadjuvant therapy
Local Recurrence (LR) Rate
Time frame: 2 years from the date of receiving neoadjuvant therapy
Organ preservation rate
Time frame: 1/2/3 years from the date of receiving neoadjuvant therapy
R0 Resection rate
Time frame: Within one week after surgery
The incidence of serious adverse events
Time frame: Within 3 months after Last medication
QLQ-C30 score
Time frame: up to 12 months
QLQ-C29 score
Time frame: up to 12 months
Low Anterior Resection Syndrome (LARS)
Time frame: up to 12 months
Quality of life and function assessment
Time frame: up to 12 months
Wexner score
Time frame: up to 12 months
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 Aug 2023.
- Derived from this study: PubMed 40860797Gu M, Guo Y, He L, Sun X, Liang T, Wang Z, Li Y, Liu Z, Wang J, Qiu X, Guo L, Chang P, Wang Q. Total neoadjuvant chemoradiotherapy plus anti PD-1 for mid-to-low locally advanced rectal cancer: study protocol of a prospective, single arm, phase II study (STARS - RC06). Front Oncol. 2025 Aug 8;15:1594927. doi: 10.3389/fonc.2025.1594927. eCollection 2025.
- 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.
PengYu Chang, Prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nCRT → (CapeOX+Sintilimab)×6 → Surgery/W&W in people with Locally Advanced Rectal Cancer and Total Neoadjuvant Treatment, run by The First Hospital of Jilin 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 15 inclusion and 17 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 Aug 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.
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 Wang Quan, Prof. (+86-431-81875602, wquan@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (CR) (time frame: Within one week after Last treatment). 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 NCT05998122, 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 18 Aug 2023.