Trials Sponsors Conditions Drugs Pricing

Conditions

Locally Advanced Colon Cancer pMMR

Keywords

colon cancerradiotherapychemotherapyimmunotherapy

Outcome Measures

Primary Outcomes (1)

3-year event-free survival
rate of 3-year event-free survival
From the date of randomization until the date of first documented disease progression or toxicity during neoadjuvant therapy that prevent surgery, local regional recurrence, distant metastasis, or death, whichever came first, assessed up to 36 months.

Secondary Outcomes (6)

pathological complete response （pCR）
one month after surgery
R0 resection rate
one month after surgery
Organ preservation rate:
one month after surgery
5-year overall survival
From the time of randomisation to 5 years.
Grade ≥3 toxicity rate
From the time of randomization to 1 year after complete treatment
+1 more secondary outcomes

Study Arms (3)

Group A （chemoradiotherapy+pd-1）

EXPERIMENTAL

Group A receives 25 Gy in 5 fractions of radiotherapy, followed by 4 cycles of CAPOX plus the PD-1 inhibitor serplulimab

Radiation: short-course radiotherapyDrug: SerplulimabDrug: CapOx(Capecitabine+ Oxaliplatin)

Group B (immunochemotherapy)

EXPERIMENTAL

Group B receives 4 cycles of CAPOX plus the PD-1 inhibitor serplulimab

Drug: SerplulimabDrug: CapOx(Capecitabine+ Oxaliplatin)

Group C (chemotherapy)

ACTIVE COMPARATOR

Interventions

short-course radiotherapyRadiation

short-course radiotherapy with 25 Gy in 5 Fractions (25 Gy/5Fx)

Group A （chemoradiotherapy+pd-1）

SerplulimabDrug

A fixed dose of 300 mg is administered by intravenous infusion on Day 1 (D1), once every 3 weeks (Q3W).

Also known as: immunotherapy, PD-1 inhibitor

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\. Aged ≥18 years, of any gender. 2. Colon adenocarcinoma confirmed by histopathology, with the tumour located \>15 cm from the anal verge on colonoscopy.
\. Locally high-risk disease demonstrated by contrast-enhanced abdominal CT or MRI, defined as tumour invasion beyond the serosa or into adjacent organs (cT4), or high-risk lymph nodes and tumour deposits. No distant metastasis (M0) identified on chest CT plus contrast-enhanced pelvic CT/MRI, or whole-body PET-CT.

Sponsors & Collaborators

Fudan University
Otherlead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Zhen Zhang, MDCONTACT+86-021-64175590 zhen_zhang@fudan.edu.cn

Hui Zhang, MDCONTACT18121299531 huizhang12@fudan.edu.cn

Zhen Zhang, MDPRINCIPAL INVESTIGATOR

Sanjun Cai, MDPRINCIPAL INVESTIGATOR

Related Publications (3)

Zhao J, Zhang H, Yu L, Hu Y, Yang Y, Dong S, Mi J, Fang Y, Qiao J, Xia F, Hu W, Zhang Z. Diagnostic CT-guided online adaptive radiotherapy for locally advanced colon cancer: a prospective implementation and feasibility study. Clin Transl Radiat Oncol. 2026 Apr 16;59:101162. doi: 10.1016/j.ctro.2026.101162. eCollection 2026 Jul.
PMID: 42028346BACKGROUND
Hu H, Zhang J, Li Y, Wang X, Wang Z, Wang H, Kang L, Liu P, Lan P, Wu X, Zhen Y, Pei H, Huang Z, Zhang H, Chen W, Zeng Y, Lai J, Wei H, Huang X, Chen J, Chen J, Tao K, Xu Q, Peng X, Liang J, Cai G, Ding K, Ding Z, Hu M, Zhang W, Tang B, Hong C, Cao J, Huang Z, Cao W, Li F, Wang X, Wang C, Huang Y, Zhao Y, Cai Y, Ling J, Xie X, Wu Z, Shi L, Ling L, Liu H, Wang J, Huang M, Deng Y; OPTICAL study group. Neoadjuvant Chemotherapy With Oxaliplatin and Fluoropyrimidine Versus Upfront Surgery for Locally Advanced Colon Cancer: The Randomized, Phase III OPTICAL Trial. J Clin Oncol. 2024 Sep 1;42(25):2978-2988. doi: 10.1200/JCO.23.01889. Epub 2024 Apr 2.
PMID: 38564700

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

ImmunotherapyImmune Checkpoint InhibitorsDrug Therapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

Zhen Zhang, MD
Fudan University
PRINCIPAL INVESTIGATOR
Sanjun Cai, MD
Fudan University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Zhang, MD

CONTACT

+86-021-64175590 zhen_zhang@fudan.edu.cn

Hui Zhang, MD

CONTACT

18121299531

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: professor

Study Record Dates

First Submitted

September 23, 2026

First Posted

October 16, 2026

Study Start

October 15, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 31, 2029

You may not qualify if:

\. Histopathological diagnosis of other colonic neoplasms, such as gastrointestinal stromal tumour, lymphoma, etc.
\. Prior treatment with PD-1 antibody, PD-L1 antibody or CTLA-4 antibody. 3. Previous or concurrent malignancy, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and papillary thyroid carcinoma.
\. Active autoimmune disease or a history of autoimmune disease (including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism). Exceptions include autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone; type 1 diabetes mellitus managed with stable-dose insulin; vitiligo; or childhood asthma/allergy that has resolved and requires no intervention in adulthood.
\. History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of solid organ transplantation and allogeneic bone marrow transplantation.
\. History of interstitial lung disease (excluding radiation pneumonitis not treated with steroids) or non-infectious pneumonitis.
\. Subjects with active pulmonary tuberculosis identified by medical history or CT scan; those with a history of active pulmonary tuberculosis within 1 year prior to enrollment; or those with a history of active pulmonary tuberculosis more than 1 year previously who did not receive standard anti-tuberculosis treatment.
\. Subjects with active hepatitis B (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL) or hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of quantification of the assay).
\. Severe impairment of cardiac, pulmonary, renal or hepatic function. 10. Uncontrolled hypertension despite antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
\. History of psychoactive substance abuse, alcoholism or illicit drug use. 12. Other factors judged by the investigator to compromise subject safety or trial compliance. Examples include severe diseases requiring concomitant treatment (including psychiatric disorders), significant laboratory abnormalities, or other familial or social factors.

Chemotherapy Combined With or Without Short-Course Radiotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for High-Risk Locally Advanced Colon Cancer With pMMR/MSS

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

Group A （chemoradiotherapy+pd-1）

Group B (immunochemotherapy)

Group C (chemotherapy)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

Group A （chemoradiotherapy+pd-1）

Group B (immunochemotherapy)

Group C (chemotherapy)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations