Locally Advanced Rectal Cancer (LARC)Phase 3NCT07020247
Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for LARC: PALACE Study
A Phase 3 study testing Anti-PD-1 antibody drug named Serplulimab, Radiotherapy and Chemotherapy in people with Locally Advanced Rectal Cancer (LARC) and Immunotherapy, run by West China Hospital at 1 site in China.
Trial summary
The study is a multicenter, randomized controlled, phase III clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR) sustained for over one year) of patients with locally advanced rectal cancer(LARC)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Rectal Cancer (LARC), Immunotherapy, Radiotherapy
- What is being tested?
- Anti-PD-1 antibody drug named Serplulimab, Radiotherapy and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2024to 31 Jan 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years old; sex is not limited.
- Patients with stage II/III rectal cancer staged under MRI or endoscopic ultrasonography and have at least one risk factor: cT4a and invasion of intestinal lumen for more than 1/2 week (measured by MRI)；cT4b(resectable)；cT3c-d with EMVI+ (upper middle rectum)；cN2；MRF+ (≤2mm)；lower rectal cancer is located on the anterior wall and tumor reaching T3 and occupying the intestinal cavity for more than 1/2 week; lower rectal cancer is mainly located on the lateral posterior wall need invading the intestinal wall (anal sphincter) ≥ 5mm； tumor of lower rectal cancer invades the external anal sphincter or levator ani muscle (stage 4) . [According to the 8th edition of the 2018 AJCC Cancer Staging Manual and the 2008 ESMO Lower Segment Colorectal Cancer Staging Criteria] . The preoperative T stage is referred to endoscopic ultrasonography or rectal MRI. The N stage is referred to abdominal CT. The M stage is referred to abdominal and thoracic CT. If symptoms occur, other appropriate imaging examinations are needed (cranial MRI or ECT) . Patients with contraindications to MRI can be interpreted with caution based on CT and endoluminal ultrasound staging. MDT should review the staging of all patients.
- The lower edge of lesion is less than 10cm from anal verge according to rigid sigmoidoscopy or rectal digital examination.
- No distant metastasis after a thorough examination .
- Pathological diagnosis of rectal adenocarcinoma,and Immunohistochemistry and/or genetic testing for MSS/pMMR;
- ECOG score: 0-1.
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- Patients with primary rectal cancer who had not received surgery prior to surgery (except for palliative ileostomy or colostomy), radiotherapy, systemic chemotherapy or other anti-tumor therapy.
- The main organ function is normal, including the following characteristics:
- ①Blood routine examination: HB ≥9g/dL, WBC ≥ 3.5/4.0×109/L，NE≥ 1.5×109/L，PLT≥ 100×109/L
- ②Biochemical examination：Crea and BIL ≤ 1.0 upper normal limit（ULN），ALT and AST≤ 2.5 upper normal limit（ULN）, ALP≤2.5×UNL，Tbil≤1.5×UNL。
- Not allergic to 5-Fu or Platinum.
- The site of radiotherapy had not previously received radiation.
- If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment. If female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF (Informed Consent Form) is signed until 8 weeks after the last dose of study drug.
- Participants are volunteered to participate in this study, sign informed consent, good compliance, cooperation with follow-up.
Who cannot join
- Patients who have previously received pelvic radiotherapy.
- Presence of active or progressive infection requiring systemic treatment, such as active tuberculosis, active hepatitis, etc.
- Presence of systemic diseases that are not stably controlled by the investigator, including diabetes mellitus, hypertension, liver cirrhosis, rheumatic immune diseases, and severe lung diseases.
- Have had prior or concurrent cancer distinct in primary site or histology (including synchronous colon cancer) , except for curatively treated cervical cancer in situ, Basal cell carcinoma of skin.
- Has any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the judgment of the investigator, has reason to suspect that the patient has a disease or condition for which the study drug is inappropriate for use, or that would affect the interpretation of the study results, or place the patient in a high-risk condition.
- Estimated inadequate patient compliance to participate in this clinical study.
- History of gastrointestinal fistula, perforation, bleeding or severe ulceration or presence of severe gastrointestinal disease that affects the absorption of oral chemotherapy drugs.
- Patients who have received solid organ transplantation or bone marrow transplantation, or have had active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
wang Xin, MD, +86 28 85423609, wangxin213@sina.com
About this study
Official title: Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for Locally Advanced Rectal Cancer：A Randomized Controlled Study (PALACE Study)
The study is a multicenter, randomized controlled, phase III clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR) sustained for over one year) of patients with locally advanced rectal cancer(LARC) treated with personalized long-course radiotherapy plus chemotherapy with or without Serplulimab. A total of 184 patients were included in this study.
Read the detailed description
Patients diagnosed with locally advanced rectal cancer (T3-4/N+) and presenting with combined risk factors, where the lower boundary of the lesion is ≤ 10 cm from the anal margin, will undergo neoadjuvant therapy. The primary endpoint of the study is the complete response rate (CR), defined as the combination of pathological complete response (pCR) and clinical complete response (cCR) sustained for over one year.
- Conditions
- Locally Advanced Rectal Cancer (LARC), Immunotherapy, Radiotherapy, Total Neoadjuvant Therapy, Anal Function Preservation
- Being tested
- Anti-PD-1 antibody drug named Serplulimab, Radiotherapy, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PD-1 antibody drug named SerplulimabDrug
Serplulimab
RadiotherapyRadiation
Radiotherapy is delivered using intensity-modulated radiotherapy (IMRT/VMAT) at a dose of 50-50.4Gy/ 25-28f(1.8-2.0Gy/d, 5f/w). For patients in the experimental group who achieve partial remission (PR) or better during the induction phase, an additional local boost dose of 6Gy/3f(2.0Gy/d, 5f/w) is administered to the PGTV.(No PGTV dose was given in the control group). For the treatment of lymph node metastasis in the lateral pelvic wall outside the mesorectal area: no additional dose is required when surgery is feasible, a sequential boost dose of 15Gy/3f is added when the lymph nodes are not surgically resectable.
ChemotherapyDrug
Capox
| Study group | Role | What they receive |
|---|---|---|
| Total Neoadjuvant Chemoradiotherapy+Serplulimab | Experimental | The experimental group intervention consists of the following:
1. Induction Phase: Two cycles of CAPOX and serplulimab prior to radiotherapy.
2. Concurrent Chemoradiotherapy: Two cycles of CAPOX and serplulimab administered concurrently with radiotherapy.
3. Consolidation Phase: Two additional cycles of CAPOX and serplulimab, initiated 2-3 weeks after completing radiotherapy.
Radiotherapy is delivered using intensity-modulated radiotherapy (IMRT/VMAT) at a dose of 50-50.4Gy/25-28f (1.8-2.0Gy/d, 5f/w). For patients in the experimental group who achieve partial remission (PR) or better during the induction phase, an additional local boost dose of 6Gy/3f (2.0Gy/d, 5f/w) is administered to the PGTV.
Tumor response is assessed 3-4 weeks after completing consolidation chemotherapy. Based on the evaluation, a decision is made to proceed with either total mesorectal excision (TME) or a watchful waiting strategy. Receives: Drug: Anti-PD-1 antibody drug named Serplulimab; Radiation: Radiotherapy; Drug: Chemotherapy |
| Total Neoadjuvant Chemoradiotherapy | Active comparator | The control group intervention consists of the following:
1. Induction Phase: Two cycles of CAPOX prior to radiotherapy.
2. Concurrent Chemoradiotherapy: Two cycles of CAPOX administered concurrently with radiotherapy.
3. Consolidation Phase: Two additional cycles of CAPOX, initiated 2-3 weeks after completing radiotherapy.
Radiotherapy is delivered using intensity-modulated radiotherapy (IMRT/VMAT) at a dose of 50-50.4Gy/25-28f (1.8-2.0Gy/d, 5f/w).
Tumor response is assessed 3-4 weeks after completing consolidation chemotherapy. Based on the evaluation, a decision is made to proceed with either total mesorectal excision (TME) or a watchful waiting strategy. Receives: Radiation: Radiotherapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Defined as the combination of pathological complete response (pCR) and clinical complete response (cCR) sustained for over one year.
Measured: 1 year
Secondary outcomes (9)
R0 resection rates
The proportion of patients achieved a complete resection with negative margin
Measured: 1 year
Disease free survival
Time from the completion of the treatment to any recurrences or distant metastases
Measured: 3 years
Anus-preserving rate
The rate of anal organ preservation patients to all patients
Measured: 1 year
Locoregional recurrence-free survival (LRFS) rates
The rate of patients without local recurrence to all the patients
Measured: 3 years
Distant metastasis free survival
Time from the completion of the treatment to any distant metastases
Measured: 3 years
Overall survival
OS is defined as the difference between the date of study enrollment to the date death due to any cause
Measured: 3 years
The adverse effects during the chemoradiotherapy
Any side effects during the chemoradiotherapy
Measured: 3 months
Quality of life (QoL)
Assessed using the Chinese version of QLQ-C30 to measure quality of life
Measured: 1 year
Surgical Safety Metrics
Surgical safety was assessed using the Clavien-Dindo classification system
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 posted13 Jun 2025
- Study start19 Nov 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jan 2028 (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.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xin, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020247
- Sponsor's protocol ID
- PALACE
- Status last verified
- Dec 2024
- First submitted
- 6 Apr 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for Locally Advanced Rectal Cancer：A Randomized Controlled Study (PALACE Study)
- ClinicalTrials.gov ID
- NCT07020247
- Acronym / sponsor ID
- PALACE
- Conditions
- Locally Advanced Rectal Cancer (LARC), Immunotherapy, Radiotherapy, Total Neoadjuvant Therapy, Anal Function Preservation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 13 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.
The study is a multicenter, randomized controlled, phase III clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR) sustained for over one year) of patients with locally advanced rectal cancer(LARC) treated with personalized long-course radiotherapy plus chemotherapy with or without Serplulimab. A total of 184 patients were included in this study.
Detailed description
Patients diagnosed with locally advanced rectal cancer (T3-4/N+) and presenting with combined risk factors, where the lower boundary of the lesion is ≤ 10 cm from the anal margin, will undergo neoadjuvant therapy. The primary endpoint of the study is the complete response rate (CR), defined as the combination of pathological complete response (pCR) and clinical complete response (cCR) sustained for over one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Neoadjuvant Chemoradiotherapy+Serplulimab | Experimental | Drug: Anti-PD-1 antibody drug named Serplulimab, Radiation: Radiotherapy, Drug: ChemotherapyThe experimental group intervention consists of the following: 1. Induction Phase: Two cycles of CAPOX and serplulimab prior to radiotherapy. 2. Concurrent Chemoradiotherapy: Two cycles of CAPOX and serplulimab administered concurrently with radiotherapy. 3. Consolidation Phase: Two additional cycles of CAPOX and serplulimab, initiated 2-3 weeks after completing radiotherapy. Radiotherapy is delivered using intensity-modulated radiotherapy (IMRT/VMAT) at a dose of 50-50.4Gy/25-28f (1.8-2.0Gy/d, 5f/w). For patients in the experimental group who achieve partial remission (PR) or better during the induction phase, an additional local boost dose of 6Gy/3f (2.0Gy/d, 5f/w) is administered to the PGTV. Tumor response is assessed 3-4 weeks after completing consolidation chemotherapy. Based on the evaluation, a decision is made to proceed with either total mesorectal excision (TME) or a watchful waiting strategy. |
| Total Neoadjuvant Chemoradiotherapy | Active comparator | Radiation: Radiotherapy, Drug: ChemotherapyThe control group intervention consists of the following: 1. Induction Phase: Two cycles of CAPOX prior to radiotherapy. 2. Concurrent Chemoradiotherapy: Two cycles of CAPOX administered concurrently with radiotherapy. 3. Consolidation Phase: Two additional cycles of CAPOX, initiated 2-3 weeks after completing radiotherapy. Radiotherapy is delivered using intensity-modulated radiotherapy (IMRT/VMAT) at a dose of 50-50.4Gy/25-28f (1.8-2.0Gy/d, 5f/w). Tumor response is assessed 3-4 weeks after completing consolidation chemotherapy. Based on the evaluation, a decision is made to proceed with either total mesorectal excision (TME) or a watchful waiting strategy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age: ≥18 years old; sex is not limited.
- Patients with stage II/III rectal cancer staged under MRI or endoscopic ultrasonography and have at least one risk factor: cT4a and invasion of intestinal lumen for more than 1/2 week (measured by MRI)；cT4b(resectable)；cT3c-d with EMVI+ (upper middle rectum)；cN2；MRF+ (≤2mm)；lower rectal cancer is located on the anterior wall and tumor reaching T3 and occupying the intestinal cavity for more than 1/2 week; lower rectal cancer is mainly located on the lateral posterior wall need invading the intestinal wall (anal sphincter) ≥ 5mm； tumor of lower rectal cancer invades the external anal sphincter or levator ani muscle (stage 4) . [According to the 8th edition of the 2018 AJCC Cancer Staging Manual and the 2008 ESMO Lower Segment Colorectal Cancer Staging Criteria] . The preoperative T stage is referred to endoscopic ultrasonography or rectal MRI. The N stage is referred to abdominal CT. The M stage is referred to abdominal and thoracic CT. If symptoms occur, other appropriate imaging examinations are needed (cranial MRI or ECT) . Patients with contraindications to MRI can be interpreted with caution based on CT and endoluminal ultrasound staging. MDT should review the staging of all patients.
- The lower edge of lesion is less than 10cm from anal verge according to rigid sigmoidoscopy or rectal digital examination.
- No distant metastasis after a thorough examination .
- Pathological diagnosis of rectal adenocarcinoma,and Immunohistochemistry and/or genetic testing for MSS/pMMR;
Key exclusion criteria (8 listed)
- Patients who have previously received pelvic radiotherapy.
- Presence of active or progressive infection requiring systemic treatment, such as active tuberculosis, active hepatitis, etc.
- Presence of systemic diseases that are not stably controlled by the investigator, including diabetes mellitus, hypertension, liver cirrhosis, rheumatic immune diseases, and severe lung diseases.
- Have had prior or concurrent cancer distinct in primary site or histology (including synchronous colon cancer) , except for curatively treated cervical cancer in situ, Basal cell carcinoma of skin.
- Has any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the judgment of the investigator, has reason to suspect that the patient has a disease or condition for which the study drug is inappropriate for use, or that would affect the interpretation of the study results, or place the patient in a high-risk condition.
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 |
|---|---|---|
| Anti-PD-1 antibody drug named SerplulimabSerplulimab | Drug | Total Neoadjuvant Chemoradiotherapy+Serplulimab |
| RadiotherapyRadiotherapy is delivered using intensity-modulated radiotherapy (IMRT/VMAT) at a dose of 50-50.4Gy/ 25-28f(1.8-2.0Gy/d, 5f/w). For patients in the experimental group who achieve partial remission (PR) or better during the induction phase, an additional local boost dose of 6Gy/3f(2.0Gy/d, 5f/w) is administered to the PGTV.(No PGTV dose was given in the control group). For the treatment of lymph node metastasis in the lateral pelvic wall outside the mesorectal area: no additional dose is required when surgery is feasible, a sequential boost dose of 15Gy/3f is added when the lymph nodes are not surgically resectable. | Radiation | Total Neoadjuvant Chemoradiotherapy, Total Neoadjuvant Chemoradiotherapy+Serplulimab |
| ChemotherapyCapox | Drug | Total Neoadjuvant Chemoradiotherapy, Total Neoadjuvant Chemoradiotherapy+Serplulimab |
Primary outcome
Complete response rate
Time frame: 1 year
Defined as the combination of pathological complete response (pCR) and clinical complete response (cCR) sustained for over one year.
9 secondary outcomes
R0 resection rates
Time frame: 1 year
Disease free survival
Time frame: 3 years
Anus-preserving rate
Time frame: 1 year
Locoregional recurrence-free survival (LRFS) rates
Time frame: 3 years
Distant metastasis free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
The adverse effects during the chemoradiotherapy
Time frame: 3 months
Quality of life (QoL)
Time frame: 1 year
Surgical Safety Metrics
Time frame: 1 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 13 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anti-PD-1 antibody drug named Serplulimab, Radiotherapy and Chemotherapy in people with Locally Advanced Rectal Cancer (LARC) and Immunotherapy, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 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 13 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xin (+86 28 85423609, wangxin213@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: 1 year). 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 13 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.