Locally Advanced Rectal Cancer (LARC)Phase 2STELLARIIINCT07040098
Optimizing Immunotherapy Combined With Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer
A Phase 2 study testing Sintilimab, Short-course radiotherapy and Long-course concurrent chemoradiotherapy in people with Locally Advanced Rectal Cancer (LARC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 sites in China.
Trial summary
This study explores the key clinical issues in the field of neoadjuvant therapy for locally advanced rectal cancer. There are three core problems with the currently recommended total neoadjuvant therapy (TNT) in the guidelines: the lack of evidence-based consensus on the timing of radiotherapy and chemotherapy, the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer (LARC)
- What is being tested?
- Sintilimab, Short-course radiotherapy and Long-course concurrent chemoradiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2025to 30 Jun 2030
- 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
- Age 18-75 years, regardless of gender;
- Pathologically confirmed rectal adenocarcinoma with immunohistochemical results indicating pMMR (proficient mismatch repair) or genetic testing confirming MSS (microsatellite stability);
- Staged as clinical stage II/III (cT3-T4N0 or cT2-4N+, no distant metastasis, per the 8th Edition AJCC Cancer Staging Manual, 2018) via MRI or endoscopic ultrasound, and meeting any one of the following:
- cT3 with tumor inferior margin ≤ 6 cm from the anal verge;
- cT3c/d with tumor inferior margin ≥ 6-12 cm from the anal verge; ③ cN2; ④ cT4; ⑤ MRF+ (mesorectal fascia involvement); ⑥ EMVI+ (extramural vascular invasion);
- ECOG performance status 0-1;
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- Meeting basic laboratory criteria (e.g., hematologic, hepatic, and renal function);
- No history of hypersensitivity to 5-Fu-based agents or platinum-based drugs;
- Patients with primary rectal cancer must have received no prior surgery (excluding palliative colostomy), chemotherapy, or other antitumor therapies from diagnosis to enrollment;
- No prior radiation to the planned radiotherapy site;
- Signed informed consent form.
Who cannot join
- Prior treatment with anti-PD-1/L1 and/or anti-CTLA-4 immunotherapy or other investigational immunotherapeutic agents;
- History of severe autoimmune diseases, including active inflammatory bowel disease (IBD) (e.g., Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., granulomatosis with polyangiitis);
- Symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis;
- Risk factors for bowel perforation, such as active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis, or other known predisposing conditions;
- History of other malignancies, except for cured non-melanoma skin cancer or cervical carcinoma in situ;
- Active infection, heart failure, myocardial infarction within 6 months, unstable angina, or uncontrolled arrhythmia;
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- Physical examination findings or clinical laboratory abnormalities deemed by the investigator to interfere with study outcomes or increase treatment-related risks, or other uncontrolled comorbidities;
- Pregnant or breastfeeding women;
- Congenital or acquired immunodeficiency disorders, including HIV infection, or history of organ/stem cell transplantation;
- Active hepatitis B (HBV-DNA ≥2000 U/mL), hepatitis C (HCV), or active tuberculosis infection;
- Prior administration of cancer vaccines or receipt of any vaccine within 4 weeks before treatment initiation (Note: Seasonal inactivated influenza vaccines are permitted; live-attenuated intranasal vaccines are prohibited);
- Concurrent use of immunomodulators, chemotherapy, investigational drugs, or long-term corticosteroids (≥10 mg/day prednisone equivalent);
- Patients with psychiatric disorders, substance abuse, or social circumstances that may compromise compliance, as assessed by the investigator;
- Hypersensitivity or contraindications to the study medications.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Beijing
Yuan Tang, +86-15011304945, tangyuan82@126.com
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen
Shenzhen
Qin Xiao, +8618390854868, xiaoqin@cicams-sz.org.cn
About this study
Official title: A Prospective, Multicenter, Randomized Clinical Trial of Optimizing Immunotherapy Combined With Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer (STELLARIII)
This study explores the key clinical issues in the field of neoadjuvant therapy for locally advanced rectal cancer. There are three core problems with the currently recommended total neoadjuvant therapy (TNT) in the guidelines: the lack of evidence-based consensus on the timing of radiotherapy and chemotherapy, the undefined number of chemotherapy cycles, and the uncertainty in the selection of the precise radiotherapy mode. In recent years, the combination of immune checkpoint inhibitors (ICIs) with the PD-1/PD-L1 inhibitors as the core and the TNT regimen has shown a trend of further enhancing tumor regression, providing a possibility for the organ function preservation of rectal cancer. However, existing clinical studies exhibit a high degree of heterogeneity in treatment strategies. In particular, there is a lack of high-quality evidence-based medical evidence in core aspects such as the timing of ICIs intervention and the combination of treatment regimens. This study is designed as a prospective, multicenter, randomized controlled phase II study. The "pick the winner" strategy for screening the optimal regimen is adopted to evaluate the efficacy of four neoadjuvant regimens (Group SCRT-4: short-course radiotherapy → 4 cycles of chemotherapy + ICIs; Group SCRT-6: short-course radiotherapy → 6 cycles of chemotherapy + ICIs; Group LCRT-4: concurrent chemoradiotherapy → 4 cycles of chemotherapy + ICIs; Group LCRT-6: concurrent chemoradiotherapy → 6 cycles of chemotherapy + ICIs). By evaluating indicators such as the complete response rate, organ preservation rate, safety, long-term survival, as well as the anal function and quality of life of patients, treatment strategies with clinical advantages will be screened out, providing an evidence-based basis for subsequent phase III confirmatory trials.
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Being tested
- Sintilimab, Short-course radiotherapy, Long-course concurrent chemoradiotherapy, CAPOX
- Keywords
- Locally advanced rectal cancer, TNT, Immunotherapy, CR rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called Immune checkpoint inhibitor
PD-1 inhibitor
Short-course radiotherapyRadiation
Also called hypofraction
Pelvic radiation, SCRT, 5 Gy x 5 alone
Long-course concurrent chemoradiotherapyRadiation
Also called CCRT
Pelvic radiation, 50 Gy in 25 fractions over 5 weeks, concurrently with capecitabine (825 mg/m2, twice a day).
CAPOXCombination product
Also called neoadjuvant chemotherapy
chemotherapy regimen, Oxaliplatin 130 mg/m2 IV day 1，Capecitabine 1000 mg/m2 twice daily PO for 14 days(3 weeks per cycle)
| Study group | Role | What they receive |
|---|---|---|
| Group SCRT-4 | Experimental | The intervention of group SCRT-4 is Short-course radiotherapy followed by neoadjuvant chemotherapy and PD-1 inhibitor, which consists of a short-course radiotherapy(SCRT, 5 Gy x 5 alone), then after 14 days of radiotherapy completed, four cycles of PD-1 inhibitor and four cycles of CAPOX will be performed. The regimen of PD-1 inhibitor and CAPOX treatment includes Sintilimab 200 mg IV, day 1，Oxaliplatin 130 mg/m2 IV day 1，Capecitabine 1000 mg/m2 twice daily PO for 14 days(3 weeks per cycle).Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients. Receives: Drug: Sintilimab; Radiation: Short-course radiotherapy; Combination Product: CAPOX |
| Group SCRT-6 | Experimental | The intervention of group SCRT-6 is Short-course radiotherapy followed by neoadjuvant chemotherapy and PD-1 inhibitor, which consists of a short-course radiotherapy(SCRT, 5 Gy x 5 alone), then after 14 days of radiotherapy completed, six cycles of PD-1 inhibitor and six cycles of CAPOX will be performed. The regimen of PD-1 inhibitor and CAPOX treatment includes Sintilimab 200 mg IV, day 1，Oxaliplatin 130 mg/m2 IV day 1，Capecitabine 1000 mg/m2 twice daily PO for 14 days(3 weeks per cycle).Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients. Receives: Drug: Sintilimab; Radiation: Short-course radiotherapy; Combination Product: CAPOX |
| Group LCRT-4 | Experimental | The intervention of group LCRT-4 is Long-course concurrent chemoradiotherapy followed by neoadjuvant chemotherapy and PD-1 inhibitor, which consists of a Long-course concurrent chemoradiotherapy (LCRT, 2 Gy x 25f, concurrently with capecitabine 825 mg/m2, twice a day), then after 14 days of radiotherapy completed, four cycles of PD-1 inhibitor and four cycles of CAPOX will be performed. The regimen of PD-1 inhibitor and CAPOX treatment includes Sintilimab 200 mg IV, day 1，Oxaliplatin 130 mg/m2 IV day 1，Capecitabine 1000 mg/m2 twice daily PO for 14 days(3 weeks per cycle).Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients. Receives: Drug: Sintilimab; Radiation: Long-course concurrent chemoradiotherapy; Combination Product: CAPOX |
| Group LCRT-6 | Experimental | The intervention of group LCRT-6 is Long-course concurrent chemoradiotherapy followed by neoadjuvant chemotherapy and PD-1 inhibitor, which consists of a Long-course concurrent chemoradiotherapy (LCRT, 2 Gy x 25f, concurrently with capecitabine 825 mg/m2, twice a day), then after 14 days of radiotherapy completed, six cycles of PD-1 inhibitor and six cycles of CAPOX will be performed. The regimen of PD-1 inhibitor and CAPOX treatment includes Sintilimab 200 mg IV, day 1，Oxaliplatin 130 mg/m2 IV day 1，Capecitabine 1000 mg/m2 twice daily PO for 14 days(3 weeks per cycle).Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients. Receives: Drug: Sintilimab; Radiation: Long-course concurrent chemoradiotherapy; Combination Product: CAPOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete response
The rate of pathological complete response plus clinical complete response
Measured: 2 months after completion of neoadjuvant therapy or 10 days after surgery
Secondary outcomes (12)
Rate of TRG grade
Dowrak TRG grade
Measured: 10 days after surgery
Tumor downstaging rate
rate of ypT0-2N0
Measured: 10 days after surgery
Rate of acute toxicities during radiation, chemotherapy ± immunotherapy
Incidence of acute toxicities during radiation, chemotherapy ± immunotherapy
Measured: 1 week after completion of neoadjuvant therapy
Rate of surgical complications
Clavien-Dindo Grade
Measured: 3 months after completion of surgery
Rate of OS
overall survival
Measured: 3 years after randomization
Rate of DFS
Disease-Free Survival
Measured: 3 years after randomization
Rate of LRR
Locoregional Recurrence
Measured: 3 years after randomization
Rate of DM
Distant Metastasis
Measured: 3 years after randomization
Organ Preservation Rate
The organ preservation rate is defined as the proportion of patients who successfully retain the rectal organ and its function through effective local treatment of the primary lesion, achieved by approaches such as a watch-and-wait (W\&W) strategy or local excision. Successful organ preservation is determined if the following criteria are met:
- Undergoing the W\&W approach without local regrowth;
- Undergoing local excision with negative resection margins and no local recurrence;
- Avoidance of total mesorectal excision (TME) surgery with preservation of functional rectal reflex pathways;
- No definitive evidence of residual local tumor;
- Absence of a permanent stoma or unclosed temporary stoma.
Measured: 3 years after randomization
Quality of life (QoL) in cancer patients
Quality of life in cancer patients will be evaluated using the European Organisation for Treatment and Research of Cancer (EORTC) Quality of Life Questionnaires QLQ-C30 . The scoring and interpretation of the QLQ-C30 scales were performed according to the EORTC guidelines. Each item is scored from 0 to 100, with higher scores indicating better functioning on the functional scales/items and more severe symptoms on the symptom scales/items.
Measured: baseline, 10 days after completion of neoadjuvant therapy, 10 days after surgery, 3 months after randomization, 6 months after randomization, 1 year after randomization, 2 years after randomization, 3 years after randomization
Quality of life (QoL) in rectal cancer patients
Quality of life in rectal cancer patients will be evaluated using the European Organisation for Treatment and Research of Cancer (EORTC) Quality of Life Questionnaires QLQ-CR29 . The scoring and interpretation of the QLQ-CR29 scales were performed according to the EORTC guidelines. Each item is scored from 0 to 100, with higher scores indicating better functioning on the functional scales/items and more severe symptoms on the symptom scales/items.
Measured: baseline, 10 days after completion of neoadjuvant therapy, 10 days after surgery, 3 months after randomization, 6 months after randomization, 1 year after randomization, 2 years after randomization, 3 years after randomization
Anal function
Anal function will be evaluated using the Wexner incontinence score. This scoring system consists of 5 items evaluating the frequency of gas incontinence, frequency of liquid incontinence, frequency of solid incontinence, frequency of wearing pads, and lifestyle alterations, with a score ranging from 0-4 for each question. The total score is calculated, with higher scores indicating poorer anal function.
Measured: baseline, 10 days after completion of neoadjuvant therapy, 10 days after surgery, 3 months after randomization, 6 months after randomization, 1 year after randomization, 2 years after randomization, 3 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal Cancer (LARC)Studies of the same condition, open and under way.
- 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
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIN JING, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040098
- Sponsor's protocol ID
- NCC5362
- Acronym
- STELLARIII
- Status last verified
- Jun 2025
- First submitted
- 20 May 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Clinical Trial of Optimizing Immunotherapy Combined With Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer (STELLARIII)
- ClinicalTrials.gov ID
- NCT07040098
- Acronym / sponsor ID
- STELLARIII / NCC5362
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Keywords
- Locally advanced rectal cancer, TNT, Immunotherapy, CR rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 26 Jun 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.
This study explores the key clinical issues in the field of neoadjuvant therapy for locally advanced rectal cancer. There are three core problems with the currently recommended total neoadjuvant therapy (TNT) in the guidelines: the lack of evidence-based consensus on the timing of radiotherapy and chemotherapy, the undefined number of chemotherapy cycles, and the uncertainty in the selection of the precise radiotherapy mode. In recent years, the combination of immune checkpoint inhibitors (ICIs) with the PD-1/PD-L1 inhibitors as the core and the TNT regimen has shown a trend of further enhancing tumor regression, providing a possibility for the organ function preservation of rectal cancer. However, existing clinical studies exhibit a high degree of heterogeneity in treatment strategies. In particular, there is a lack of high-quality evidence-based medical evidence in core aspects such as the timing of ICIs intervention and the combination of treatment regimens. This study is designed as a prospective, multicenter, randomized controlled phase II study. The "pick the winner" strategy for screening the optimal regimen is adopted to evaluate the efficacy of four neoadjuvant regimens (Group SCRT-4: short-course radiotherapy → 4 cycles of chemotherapy + ICIs; Group SCRT-6: short-course radiotherapy → 6 cycles of chemotherapy + ICIs; Group LCRT-4: concurrent chemoradiotherapy → 4 cycles of chemotherapy + ICIs; Group LCRT-6: concurrent chemoradiotherapy → 6 cycles of chemotherapy + ICIs). By evaluating indicators such as the complete response rate, organ preservation rate, safety, long-term survival, as well as the anal function and quality of life of patients, treatment strategies with clinical advantages will be screened out, providing an evidence-based basis for subsequent phase III confirmatory trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group SCRT-4 | Experimental | Drug: Sintilimab, Radiation: Short-course radiotherapy, Combination Product: CAPOXThe intervention of group SCRT-4 is Short-course radiotherapy followed by neoadjuvant chemotherapy and PD-1 inhibitor, which consists of a short-course radiotherapy(SCRT, 5 Gy x 5 alone), then after 14 days of radiotherapy completed, four cycles of PD-1 inhibitor and four cycles of CAPOX will be performed. The regimen of PD-1 inhibitor and CAPOX treatment includes Sintilimab 200 mg IV, day 1，Oxaliplatin 130 mg/m2 IV day 1，Capecitabine 1000 mg/m2 twice daily PO for 14 days(3 weeks per cycle).Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients. |
| Group SCRT-6 | Experimental | Drug: Sintilimab, Radiation: Short-course radiotherapy, Combination Product: CAPOXThe intervention of group SCRT-6 is Short-course radiotherapy followed by neoadjuvant chemotherapy and PD-1 inhibitor, which consists of a short-course radiotherapy(SCRT, 5 Gy x 5 alone), then after 14 days of radiotherapy completed, six cycles of PD-1 inhibitor and six cycles of CAPOX will be performed. The regimen of PD-1 inhibitor and CAPOX treatment includes Sintilimab 200 mg IV, day 1，Oxaliplatin 130 mg/m2 IV day 1，Capecitabine 1000 mg/m2 twice daily PO for 14 days(3 weeks per cycle).Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients. |
| Group LCRT-4 | Experimental | Drug: Sintilimab, Radiation: Long-course concurrent chemoradiotherapy, Combination Product: CAPOXThe intervention of group LCRT-4 is Long-course concurrent chemoradiotherapy followed by neoadjuvant chemotherapy and PD-1 inhibitor, which consists of a Long-course concurrent chemoradiotherapy (LCRT, 2 Gy x 25f, concurrently with capecitabine 825 mg/m2, twice a day), then after 14 days of radiotherapy completed, four cycles of PD-1 inhibitor and four cycles of CAPOX will be performed. The regimen of PD-1 inhibitor and CAPOX treatment includes Sintilimab 200 mg IV, day 1，Oxaliplatin 130 mg/m2 IV day 1，Capecitabine 1000 mg/m2 twice daily PO for 14 days(3 weeks per cycle).Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients. |
| Group LCRT-6 | Experimental | Drug: Sintilimab, Radiation: Long-course concurrent chemoradiotherapy, Combination Product: CAPOXThe intervention of group LCRT-6 is Long-course concurrent chemoradiotherapy followed by neoadjuvant chemotherapy and PD-1 inhibitor, which consists of a Long-course concurrent chemoradiotherapy (LCRT, 2 Gy x 25f, concurrently with capecitabine 825 mg/m2, twice a day), then after 14 days of radiotherapy completed, six cycles of PD-1 inhibitor and six cycles of CAPOX will be performed. The regimen of PD-1 inhibitor and CAPOX treatment includes Sintilimab 200 mg IV, day 1，Oxaliplatin 130 mg/m2 IV day 1，Capecitabine 1000 mg/m2 twice daily PO for 14 days(3 weeks per cycle).Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-75 years, regardless of gender;
- Pathologically confirmed rectal adenocarcinoma with immunohistochemical results indicating pMMR (proficient mismatch repair) or genetic testing confirming MSS (microsatellite stability);
- Staged as clinical stage II/III (cT3-T4N0 or cT2-4N+, no distant metastasis, per the 8th Edition AJCC Cancer Staging Manual, 2018) via MRI or endoscopic ultrasound, and meeting any one of the following:
- ECOG performance status 0-1;
- Meeting basic laboratory criteria (e.g., hematologic, hepatic, and renal function);
Key exclusion criteria (14 listed)
- Prior treatment with anti-PD-1/L1 and/or anti-CTLA-4 immunotherapy or other investigational immunotherapeutic agents;
- History of severe autoimmune diseases, including active inflammatory bowel disease (IBD) (e.g., Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., granulomatosis with polyangiitis);
- Symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis;
- Risk factors for bowel perforation, such as active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis, or other known predisposing conditions;
- History of other malignancies, except for cured non-melanoma skin cancer or cervical carcinoma in situ;
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 |
|---|---|---|
| SintilimabAlso: Immune checkpoint inhibitorPD-1 inhibitor | Drug | Group LCRT-4, Group LCRT-6, Group SCRT-4, Group SCRT-6 |
| Short-course radiotherapyAlso: hypofractionPelvic radiation, SCRT, 5 Gy x 5 alone | Radiation | Group SCRT-4, Group SCRT-6 |
| Long-course concurrent chemoradiotherapyAlso: CCRTPelvic radiation, 50 Gy in 25 fractions over 5 weeks, concurrently with capecitabine (825 mg/m2, twice a day). | Radiation | Group LCRT-4, Group LCRT-6 |
| CAPOXAlso: neoadjuvant chemotherapychemotherapy regimen, Oxaliplatin 130 mg/m2 IV day 1，Capecitabine 1000 mg/m2 twice daily PO for 14 days(3 weeks per cycle) | Combination product | Group LCRT-4, Group LCRT-6, Group SCRT-4, Group SCRT-6 |
Primary outcome
Rate of complete response
Time frame: 2 months after completion of neoadjuvant therapy or 10 days after surgery
The rate of pathological complete response plus clinical complete response
12 secondary outcomes
Rate of TRG grade
Time frame: 10 days after surgery
Tumor downstaging rate
Time frame: 10 days after surgery
Rate of acute toxicities during radiation, chemotherapy ± immunotherapy
Time frame: 1 week after completion of neoadjuvant therapy
Rate of surgical complications
Time frame: 3 months after completion of surgery
Rate of OS
Time frame: 3 years after randomization
Rate of DFS
Time frame: 3 years after randomization
Rate of LRR
Time frame: 3 years after randomization
Rate of DM
Time frame: 3 years after randomization
Organ Preservation Rate
Time frame: 3 years after randomization
Quality of life (QoL) in cancer patients
Time frame: baseline, 10 days after completion of neoadjuvant therapy, 10 days after surgery, 3 months after randomization, 6 months after randomization, 1 year after randomization, 2 years after randomization, 3 years after randomization
Quality of life (QoL) in rectal cancer patients
Time frame: baseline, 10 days after completion of neoadjuvant therapy, 10 days after surgery, 3 months after randomization, 6 months after randomization, 1 year after randomization, 2 years after randomization, 3 years after randomization
Anal function
Time frame: baseline, 10 days after completion of neoadjuvant therapy, 10 days after surgery, 3 months after randomization, 6 months after randomization, 1 year after randomization, 2 years after randomization, 3 years after randomization
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 26 Jun 2025.
- Individual participant dataSharing planned: No
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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.
2 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 Sintilimab, Short-course radiotherapy and Long-course concurrent chemoradiotherapy in people with Locally Advanced Rectal Cancer (LARC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 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 11 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 Yuan Tang (+86-15011304945, tangyuan82@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete response (time frame: 2 months after completion of neoadjuvant therapy or 10 days 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 26 Jun 2025.