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Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer

ConditionColon Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

This study aims to elucidate the regression effects of neoadjuvant chemotherapy combined with immunotherapy and adjuvant therapy in locally advanced MSS colon cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old and ≤75 years old.

Pathologically diagnosed MSS or pMMR-type colon adenocarcinoma.

The lower edge of the tumor is more than 12cm from the anus as measured by colonoscopy and the lower edge of the tumor cannot be directly palpated during rectal examination.

Enhanced CT stage T3/4 or T1-4N+ without multiple primary tumors or distant metastasis.

Disqualifiers

Refused to participate in this study.

Multifocal colorectal cancer.

History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers.

Cannot tolerate chemotherapy, such as but not limited to bone marrow suppression.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oxaliplatin

    Drug

    Oxaliplatin 130mg/m2 for inducing chemotherapy on Day 1 every 3 weeks and repeat for 4 cycles. The dose reduction protocol for oxaliplatin-induced toxicity was implemented according to the report in BJC (2018) 118:1322-1328.

  • Capecitabine

    Drug

    Oral Capecitabine 1000 mg/m2 twice daily combined with oxaliplatin chemotherapy from Day 1 to Day 14 every 3 weeks and repeat for 4 cycles. The dose reduction protocol for capecitabine-induced toxicity was implemented according to the report in BJC (2018) 118:1322-1328.

  • Anti-PD-L1 Monoclonal Antibody

    Drug

    The incidence of adverse events with Anti-PD-L1 Monoclonal Antibodies is relatively low. Based on phase I clinical trial data of Envafolimab, a dose reduction design was conducted to minimize the incidence of adverse events while ensuring therapeutic efficacy. In the two cohorts of the efficacy-enhancing design, a reduced dose of 100mg/0.5ml IH QW will be used for 6 weeks. The PD-L1 monoclonal antibody (Envafolimab) dose adjustment was implemented according to the prescribing information.

  • Clostridium butyricum

    Drug

    Clostridium butyricum is treated with Miyarisan 588 powder, 160mg/day (4 packets/day) taken orally for a total of 6 weeks.There have been no reports of adverse reactions for Lactobacillus. There is no predetermined reduction plan.

  • Colectomy

    Procedure/Surgery

    The specific surgical approach, whether it be laparoscopic or open surgery, is determined by the surgeon. The tumor blood supply is ligated and cut at the root of the mesentery, and the margin of resection should be no less than 10cm. Complete resection of the mesocolon (CME) is performed in conjunction.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Standard chemotherapy control cohortExperimental treatment 3 interventions
Group B: Enhancement regimen of combined Anti-PD-L1 monoclonal antibodyExperimental treatment 4 interventions
Group C: Enhancement regimen of combined lactobacillus and Anti-PD-L1 monoclonal antibodyExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

TRG0/1

The sum of tumor regression grades TRG0(disappearance of tumor) and TRG1(scattered residual tumor)(AJCC standard).

Time frame
1 day of postoperative pathological examination.

Secondary outcomes

1

AE

the rate of adverse event（AE).

Time frame
Adverse events (NCI CTC AE 5.0) that occurred from the first day of induction chemotherapy to one day before the surgery date(up to half a year).
2

Surgical Complication

the rate of surgical complication during or after operation.

Time frame
From the day of surgery to 30 days after the operation, including intraoperative and postoperative complications.
3

DFS

3-year Disease-free survival.

Time frame
From date of the patient signs the informed consent form until the date of earliest occurrence of the patient's tumor recurrence or death，whichever came first, assessed up to 36 months.
4

OS

5-year Overall survival.

Time frame
From the date of the patient signs the informed consent form until the date of the patient's death, assessed up to 60 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
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